Pharma Raw Material Suppliers

AARBEE INTERNATIONALAAR VEE & COMPANY

AAY CEE ENTERPRISES

ABHINANANDAN RASAYAN PVT. LTD

ABHISHEK ORGANIC PVT LTD

ADD BIOTECH

AFFY PHARMA PVT. LTD.

AJMERA TRADING& IMPEX PVT .LTD.

AKASH PUROCHEM(PO LIMITED

AKSHAYA LABORATORIES PVT LTD

ALIGNS INTERNATIONAL

AMIT FINE CHEM

AMIT PHARMA- CHEM

AMIT TRADING COMPANY

ANUSHA ASSOCIATE

APEX PHARMA

APT INTERNATIONAL

ARIL PHARMACUTICALS

AROCHEM INDUSTRIES

ARORA MATTHTEY LIIMITED

ATUL CHEMICALS

B.SHAH &SONS

BACHEM AG

BEIJING ZIZHU PHARMACEUTICALS CO.LTD

BHAKTI PETROCHEM PVT. LTD.

BHATIA RASAYAN UDYOG PVT LTD.

C.M FLAVOURS & FRAGNANCES

CENTRAL DRUG HOUSE

CHANDRA BIOTECH

CHEMEX CHEMICALS

CHEMFIELD INC

CHEMICAL PROCESS CONSULTANT

CHEMIPACK COORPORATION

COREL PHARMA

COSMOS INTERNATIONAL

CSPC ZHONGNUO PHARMACEUTICALS (SJZ)CO.LTD.

CRYSTAL PHARMA

DAYARAM HEALTHCARE

DAZLE COORPORATION

DD RAW PHARMA

DEEKAY COORPORATION

DESICCA CHEMICALS

DESMO EXPORTS LIMITED

DEVSON IMPEX PVT.LTD.

DILIP KUMAR HEALTHCARE PVT.LTD

DISHMAN PHARMACEUTICALS AND CHEMICALS LIMITED

DIVINE PHARMACEUTICAL

D.K. PHARMACHGEM PVT.LTD

DMT INTERNATIONAL

DOLFIN INTERNATIONAL

DPB ANTIBIOTICS

EAGLE CHEMICAL WORKS

ELITE CHEMICALS

EMBEE PHARMA SERVICES PVT. LTD.

EMCO DYESTUFF PVT. LTD.

EMKAY PHARMA PVT. LTD.

ENZAL CHEMICALS (INDIA ) LTD.

ENVEE DRUGS PRIVATE LIMITED

FINECHEM PVT. LTD.

FIRMENICH AROMATICS (INDIA) PVT. LTD.

FLORA CHEMICALS

FORBES PHARMACEUTICALS

G.C PHARMIE LTD.

GANGOTARI INORGANIC (P) LTD.

GAURAV ENTERPRISES

GAUTAM PHARMA CHEM

GLOBAL PHARMA

GORANG INTERNATIONAL

GUFIC BIOSCIENCES LIMITED

GUJARAT TRADING COORPORATION

GUPTA TRADING

HARISH ENTERPRISE

HARISH TRADING COORPORATION

HEALTHCARE MEDICINE

HEMINDS

HENIKS INC

HINDUSTAN CHEMICAL & PHARMA CHEMICAL

INDO AROMATICS PVT. LTD.

INFINIUM PHARMACHEM PVT. LTD.

INTERNATIONAL DRUG &CHEMICAL CO.

INTERNATIONAL SCIENTIFIC INSTRUMENT CO.

IOL CHEMICALS AND AND PHARMACEUICALS LIMITED

J.B.KHOKHANI &CO.

JAKSONS PHARMA

JAY CHEM MARKETING

JAY CHEMICALS

JIGNA ENTERPRISE

JPN PHARMA PVT.LTD.

K.RASIKLAL EXIM PVT.LTD.

K.SEVANTILAL &COM

KAHAN PHARMACEUTICALS

KETAN PHARMA

KHANDEL EAL LABORATORIES PVT.LTD

KRISHNA CHEMICALS

KRISHNA SOLVECHEM LTD.

LAXACHEM ORGANICS PVT.LTD.

LIKIR CHEMICALS

LONZA COLOGNE GMBH

MAGUS ORGANOCHEM

MAHALAXMI CHEMI PHARMA

MAHAVEER AGENCY

MALODY HEALTHCARE PVT.LTD.

MANAV DRUGS PVT.LTD

MANISH CHEMICALS

MAPS LABORATORIES PVT.LTD.

MARS HEALTHCARE PVT.LTD.

MEDI PHARMA DRUG HOUSE

MEHTA PHARMACEUTICAL INDL.

MESHA PHARMA PVT.LTD

MODERN DRUGS AND CHEMICALS

MODI CHEMI PHARMA PVT. LTD.

MONARCH PHARMA CHEM

MULJI MEHTA SONS PVT. LTD.

MUMBAI PHARMA-CHEM

NAVPAD CHEMICALS

NAVNIDH PHARMA LAB

NECTAR LIFESCIENCES PVT. LTD.

NEELKANTH MINECHEM PHARMA

NEHA CHEMICALS

NEMI PHARMA CHEM

NEW DRUGS &CHEMICAL CO.

NIKAVA PHARMACEUTICAL INDUSTRIES

NIMEX PVT. LTD.

OM LABORATORIES

OMKAR SPECIALITY CHEMICAL LTD.

PANCHSHEEL ORGANIC LTD.

PARAS ORGANICS

PARTH ANTIBIOTICS PVT. LTD

PASSIM MEDICHEM AGENCIES

PEARL PHARMACEUTICAL

PELCOAT FORMULATIONS

PHAEX POLYMERS PVT. LTD

PHARMICA

POOJA CHEMICALS

PRAGATI CHEM IMPEX PVT. LTD

PRAGATI RAW PHARMA PVT. LTD.

PRATAP ORGANICS

PRAVINCHANDRA & Co

PRECIOUS PHARMA

PRUDENCE PHARMA CHEM

PUJA ENTERPRISES

RACHEM PHARMA LTD

RAHUL SUGAR PRODUCT

RAJSHI PHARMA PVT. LTD

RATAN CHAND & Co.

RELY CHEM

RH ORGANA CHEMICALS

RHYTHM HEALTHCARE

RONAK CHEMICALS

RUMIT INTERNATIONAL

RUSKIN CHEMIPHARMA

RYCE YASH INDIA

S.S PHARMACHEM

SAINATH EXPIMPO

SAIRAM CREATIONS

SALICYLATES & CHEMICALS PVT. LTD

SAM ORGANICS LTD.

SAMPAN ENTERPRISES

SARVODAYA ENTERPRISES

SAURAV CHEMICALS LIMITED

SEA-SHELL CHEMICALS PVT. LTD.

SHANDONG TIANLI PHARMACEUTICALS CO. LTD.

SHILPA MEDICARE LIMITED

SHREE RAJCHEM

SHREE KRUSHNA CHEMICALS

SHREE SAI BABA CHEMICAL INDUS

SHREE SIDDHI VINAYAK PHARMA CHEM

SHREE SIDHAMBIKA PHARMA PVT. LTD

SHUBHAM PHARMACHEM PVT. LTD

SIBRAM PHARMACEUTICALS

SIDDHARTH PHARMA

SIDDHIVINAYAK PHARMA

SNEHA MEDICARE PVT LTD

SREENATH CHEMICALS

SRIKEM LABORATORIES PVT. LTD.

STANDARDCON PVT. LTD

STEAMLINE INDUSTRIES LTD.

SUCHEM INTERNATIONAL

SUKHA CHEMICAL INDUSTRIES

SUNIL CHEMICALS

SUN MOON INDUSTRIES

SUZHOU PHARMA GROUP Co. LTD

TANISHA PHARMA

TITAN LABORATORIES PVT. LTD

TODY BROTHERS PVT. LTD

TRADEWEL CORPORATION

TRICHEM

TRISHA CHEM

ULTRATECH INDIA LIMITED

UMA BROTHERS

UNICORN PETROLEUM INDUSTRIES PVT LTD

UNIMEX PVT. LTD.

UNITRADE AGENCIES

VADIANT PHARMA & TECH

VAISHALI PHARMA PVT LTD

VERGO PHARMARESEARCH

VIJLAK PHARMA LTD.

VINAY PHARMA

VISION PHARMA

VITAL THERAPEUTICS & FORMULATIONS PVT. LTD.

WEST COAST PHARMACEUTICAL

MELDI ESTATE PHARMACEUTICAL

YASHICA PVT. LTD

YASHUA BIO-TECH

ZEN BIOTECH PVT. LTD.

How to patent a product by your choice name?

Query:How to patent a product by your choice name?

Response:

You can patent any product that is unique in all aspects and all rights reserve to you. You need to apply for patent to controller general of patents, designs and Trademark. Your product should comply with all features required for patent. Should not resemble with any existing products and should be unique in all manners from existing products.

You can give your product a name of your choice and can file for patent at Office of controller of General of Patents, Designs and Trademarks.

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How should I further proceed and minimum budget for marketing company?

Query:Thank you first of all for your wonderful blog.
I am a MD Pharmacology Doctor. I want to start my own pharma company. But I don’t have any marketing or sales experience. How should I further proceed and minimum budget I need to start. My family member is M. Pharmacy registered. And I am at the start of my career. Is it right time to do this.

Response:

Read complete requirement for starting pharma marketing company here

Minimum budget requirement, you can read at our article: How much investment is required to start pharma comapny?

Without sale and marketing experience you have to suffer at some levels. You can proceed with hiring anyone having sales and marketing experience. At career starting level it is not recommended to start any business. One should proceed in business when he/she has one secure and established income source. Otherwise it is more difficult to make adjustment in both way.

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

What are the things/papers you should keep in mind while purchasing a pharma manufacturing plant in India?

Query:I would like to know what are the things/papers you should keep in mind while buying a pharma manufacturing plant in India?

 

Response:

Things to be consider are:

Read in details about Machinery and business plan for pharmaceutical manufacturing read here

Hope above information is useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Which one is Better between Own Marketing Company or Franchise Marketing?


Query:

At first I’d like to thank you all for your valuable information on ‘how to start a own pharmaceutical company in India‘. It was quite informative. But I want information as per my own profile and need. I’m having a experience of eight years in pharmaceutical sales and marketing with the companies like ————————— and currently working with ————————-.
Sir/Ma’m I wanna be a pharma entrepreneur and which mode would be the best for me to start with it- by registering own company or through franchises? I want to operate it in north Bihar. The Kosi region and the Tirhut region at first. Please give your valuable guidance on it. Looking forward for your kind support.

Response:

Your decision depend at your financial situation. Franchise marketing will need less investment while marketing company will require huge amount. Both has own advantage and disadvantage. We will discuss here so you can decide which one is better option for you.

  • Franchise marketing requires less investment and can be started instantly while own pharma marketing company requires more investment and take time period to start in starting.
  • In Franchise marketing, you can launch a good number of products at once without fear of much loss & expiry due to minimum quantity (i.e. 200 tab/ 500 tab etc.) as per need while in pharma marketing company, you have to get manufactured product at batch size basis. Minimum of twenty to thirty thousand tablet will be required to place order.
  • In Franchise Marketing, Franchise company brand names and company name will be promoted while in own marketing company, your own company name and brand name will be promoted.
  • In Franchise Marketing, you will not have to invest at promotional and marketing material because that’s the responsibility of company whereas in own company you will also have to invest at promotional and marketing material.
  • In franchise marketing, you can invest your whole time at promotion and marketing only, you don’t need to concentrate at procurement of products whereas in own company, you have to divest your time at procurement along with marketing.
  • In Franchise marketing, any time company can stop to supply its products or can supply to another distributor in your area whereas in marketing company, if one manufacturer refuse to manufacture, you can get manufactured your brand names from other one.
  • In Franchise marketing, you have to depend at company strategy for launching new molecules in market whereas in own company, you can launch new products depend at market demand.
  • In both cases, you will be requirement of Wholesale Drug License and GST Number

Depend at above factors, you can decide which will be better for you. We recommend you to start with franchise marketing with minimum invest. After achieving a particular stage, you start to launch your company by getting manufactured latest molecules one by one according to market demand.

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Read Related Articles:

How to proceed for setting-up Carrying and Forwarding (C&F) Agent

Query:
Hello, firstly whom to approach and how to proceed for setting up of C&F …….I am from Hyderabad and I have minimal to nil knowledge about C&f. Do guide me with the various steps involved in setting up of C&F.

 

Response:

First you have finalize company, you want to start c&f. Finalizing vendor is most important aspect of any business.

Complete all documentations and formalities. For pharma carrying and forwarding agent read complete detail about documentation here

After that you will need of setting up your distribution network. Carry and Forwarding’s work is to supply to stockist or distributors. For proper and smooth business, you should have strong distribution network. Read in detail about How to develop strong delivery, distribution and supply network?

Concentrate at building your network to become successful in c&f business.

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Manufacturing of Parenteral Preparations (Injections, Large Volume Parenterals, Small Volume Parenterals)

In this article we will discuss about manufacturing process. Documentations, Requirements and other formalities to start parenteral dosage form manufacturing company read by clicking this link.

Parenteral Preparations are the preparations used administration by injections, infusions or implementations into body and directly injected into veins, muscles, under the skin or more specialized tissue such as spinal cord. These are sterile and pyrogen free liquids or solid dosage forms and may contain one or more active ingredients. Parenteral preparations are packed into either single dose or multi dose container.

Technical Staff:

Non Technical Staff:

  • Machine Operators
  • Helpers

Parenteral preparations are in two forms:

  • Liquid Parenateral Preparations
  • Dry Powder Parenteral Preparation

Both type of preparation follow different type of procedure for preparing parenterals.

Types of parenteral Preparations

  • Single Dose Parenterals
  • Multiple Dose Parenterals

Section Required:
For Dry Injection:

  • Sterile Raw Material Section
  • Washing Section
  • Terminal Sterilization Section
  • Autoclave Sterilization Section
  • Filling Section
  • Capping and Sealing Section
  • Labeling and Packaging Section

For Liquid Injections:

  • Warehouse
  • Washing Section
  • General Production Section
  • Weighing, mixing and Transfer Section
  • Sterilization Section
  • Filling Section
  • Capping and Sealing Section
  • Labeling and Packaging Section

Parenteral Preparations require sterile pyrogen free atmosphere. Procedure involved in parenteral manufacturing:

For Dry Injections:

  • Dispensing of Raw Material, API and Packaging Material
  • Raw material and API ware-house should maintain aseptic area
  • Washing, drying and Sterilization of Vials, Rubber stoppers, cap and sealing material
  • Vials are sterilized and pyrozen free by means of Terminal at temperature more than 300 degree.
  • Rubber cap and heat sensitive material is sterilized through Autoclave
  • If raw material is not sterilized, material is sterilized through Autoclave
  • After Sterilization, Vials are filling with sterilized raw material. Continuous inspection and documentation is essential.
  • After filling vials go for capping and sealing.
  • Then labeling and Packaging is conducted

For Liquid Parenteral Products:

  • Dispensing of Raw, API and Packaging material
  • Raw material and API ware-house should maintain aseptic area
  • Washing, drying and Sterilization of Vials, Rubber stoppers, cap and sealing material
  • Vials are sterilized and pyrozen free by means of Terminal at temperature more than 300 degree.
  • Rubber cap and heat sensitive material is sterilized through Autoclave
  • Preparation of Vehicle or solution
  • Mix API and other raw material in above prepared preparation
  • Filtration of whole solution for sterilization
  • Filling
  • Sealing
  • Packaging
  • Storage

Equipments and Machinery:

  • Storage equipments for ampoules, Ampoules and Closures
  • Washing and Drying Equipments
  • Dust proof storage equipment including cold storage and refrigerator
  • Water Still
  • Mixing and Preparation Containers and Tanks
  • Mixing Equipments
  • Filtration Equipments
  • Hot air sterilizer
  • Benches and tables
  • Bacteriological Filters
  • Laminar Flow work station

Essential Steps:

  • Products shall be released only after complete filling and testing.
  • Result of the tests relating to sterility, pyrogens, and Bacterial endotoxins shall be maintained in the analytical records.
  • Validation details and simulation trail records shall be maintained separately,
  • Records of environmental monitoring like temperature, humidity, microbilogical data, etc. shall be maintained. Records of periodic servicing of HEPA filters, sterilizers and other periodic maintenance of facilities and equipment carried out also be maintained.
  • Separate facilities shall be provided for filling-cum-sealing of Small Volume Parenterals in glass containers and/or plastic containers,
  • It is advisable to provide separate facilities for manufacture of Large Volume Parenterals in glass containers and / or plastic containers.
  • For manufacture of Large Volume Parenterals in plastic containers, it is advisable to install automatic (with all operations) Form–Fill-Seal machines having one continuous operation.

 

 


Specific Requirements in Brief Only:
(Ref: Schedule M)

For complete information: Download Schedule M here: 

1. General Specifications: General Sterile products, being very critical and sensitive in nature, a very high degree of precautions, prevention and preparations and needed. Dampness, dirt and darkness are to be avoided to ensure aseptic conditions in all areas. There shall be strict compliance in the prescribed standards especially in the matter of supply of water, air, active materials and in the maintenance of hygienic environment.

2. Building and Civil Works:

  • Building should be constructed to avoid any cracks
  • Location should avoid contamination and leakage
  • All sections and departments shall be clearly separated from each other.
  • Walls, floors and ceiling should be impervious, non-shedding, non-flaking and non-cracking. Flooring should be unbroken and provided with a cove both at the junction between the wall and the floor as well as the wall and ceiling. Walls shall be flat, and ledges and recesses shall be avoided. Wherever other surfaces join the wall (e,g, sterilizers, electric sockets, gas points etc.) these shall flush the walls. Walls shall be provided with a cove at the joint between the ceiling and floor
  • Change rooms with entrance shall have air locks and separate exit space from the aseptic area.
  • Material transfer between aseptic areas and outside shall be through suitable airlocks or pass-boxes. Doors of such airlocks and pass-boxes shall have suitable interlocking arrangements.

3. Air Handling System (Central Air Conditioning): Air Handling Units for sterile product manufacturing areas shall be different from those for other areas. Critical areas, such as the aseptic filling area, sterilized components unloading area and change room conforming to Grades B, C and D respectively shall have separate air handling units. The filter configuration in the air handling system shall be suitably designed to achieve the Grade of air which shall be achieved by providing laminar air flow work stations with suitable HEPA filters or isolator technology

4. Environmental Monitoring: All environmental parameters listed shall be verified and established at the time of installation and thereafter monitored at periodic intervals.

5. Garments: This section covers garments required for use by personnel working only in aseptic area. Outdoor clothing shall not be brought into the sterile areas. Only clean, sterilized and protective garments shall be used at each work session where aseptic filtration and filling operations are undertaken and at each work shift for products intended to be sterilized, post-filling. The mask and gloves shall be changed at every work session in both instances.

6. Sanitation: There shall be written procedures for the sanitation of sterile processing facilities. Employees carrying out sanitation of aseptic areas shall be trained specifically for this purpose.

7. Equipments: The special equipment required for manufacturing sterile products includes component washing machines, steam sterilizers, dry heat sterilizers, membrane filter assemblies, manufacturing vessels, blenders, liquid filling machines, powder filling machines, sealing and labeling machines, vacuum testing chambers, inspection machines, lyophilisers, pressure vessels etc. suitable and fully integrated washing sterilizing filling lines may be provided, depending upon the type and volume of activity.

8. Water System: Potable water meeting microbiological specification of not more than 500 cfu/ml and indicating absence of individual pathogenic microorganisms, Escherichia coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa per 100 ml sample shall be used for the preparation of purified water

9. Manufacturing Process: Manufacturing of sterile products shall required defined conditions and environment.

10. Form-Fill-Seal Technology or Blow, Fill-Seal Technology: Form-Fill-Seal units are specially built automated machines in which through one continuous operation, containers are formed from thermoplastic granules, filled and then sealed. Blow, fill-seal units are machines in which containers are moulded / blown (pre-formed) in separate clean rooms, by non-continuous operations.

11. Product Container and Closures: 1 All containers and closures intended for use shall comply with the pharmacopoeial and other specified requirements.

12. Documentation: The manufacturing records relating to manufacture of sterile products shall indicate the following details:-

  • Serial number of the Batch Manufacturing Record.
  • Name of the product
  • Reference to Master Formula Record.
  • Batch/Lot number
  • Batch/Lot size.
  • Date of commencement of manufacture and date of completion of manufacture.
  • Date of manufacture and assigned date of expiry.
  • Date of each step in manufacturing.
  • Names of all ingredients with the grade given by the quality control department.
  • Quality of all ingredients.
  • Control reference numbers for all ingredients.
  • Time and duration of blending, mixing, etc. whenever applicable.
  • PH of solution whenever applicable.
  • Filter integrity testing records
  • Temperature and humidity records whenever applicable
  • Records of plate-counts whenever applicable.
  • Results of pyrogen and/or bacterial endotoxin & toxicity.
  • Results of weight or volume of drug filled in containers.
  • Bulk sterility in case of aseptically filled products.
  • Leak test records.
  • Inspection records.
  • Sterilization records including autoclave leakage test records, load details, date, duration, temperature, pressure, etc.
  • Container washing records.
  • Total number of containers filled.
  • Total numbers of containers rejected at each stage
  • Theoretical yield, permissible yield, actual yield and variation thereof.
  • Clarification for variation in yield beyond permissible yield.
  • Reference numbers of relevant analytical reports.
  • Details of reprocessing, if any.
  • Name of all operators carrying out different activities.
  • Environmental monitoring records.
  • Specimens of printed packaging materials.
  • Records of destruction of rejected containers printed packaging and testing.
  • Signature of competent technical staff responsible for manufacture and testing.

Manufacturing of Liquids Dosage Form i.e. Syrups

Liquid Manufacturing:

In this article we will discuss about manufacturing process. Documentations, Requirements and other formalities to start Liquid manufacturing company read by clicking this link.

Liquid manufacturing is not a complex process. Most of liquids is prepared in Sugar syrup base except sugar free liquids. Sugar grade and quality should be high. Water used for making syrup is De-mineralized water for prevention of any reaction to mineral present in water with ingredients used for preparation.

Technical Staff:

Non Technical Staff:

  • Machine Operators
  • Helpers
Section Required:
  • Washing Section
  • Sugar Mixing Section
  • Storage Section
  • Filling and Sealing Section
  • Labeling and Packaging Section
Machinery Used:
  • Mixing and storage tanks (stainless steel),
  • Jacketted Kettle / Stainless steel tank (steam, gas or electrically heated).
  • Portable stirrer (electrically operated)
  • A colloid mill or suitable emulsifier (electrically operated)
  • Suitable filtration equipment (electrically operated)
  • Semi-automatic/automatic bottle filling machine
  • Pilfer proof cap sealing machine.
  • Water distillation unit or deioniser
  • Clarity testing inspection units.
Process should be conducted in hygienic conditions under good manufacturing practice. You have to careful about temperature and PH of liquid for stability and homogeneous throughout self life of preparation.

Two type of liquid manufacturing plants are used for liquid manufacturing:

  • Semi-Automatic Plants
  • Fully Automatic Plants

Procedure of Liquid Manufacturing:

  • Dispensing: Accurately weigh Sugar, active ingredients and other excipients.
  • Take D.M. water in sugar melting vessel.
  • Sugar grading and sieving
  • Transfer sugar into vessel containing D.M. water and mix
  • Heating of vessel with continuous stirring for mixing of sugar in DM water for syrup base
  • After preparation of syrup base, filter it to remove impurities from it.
  • After filtration transfer again it in sugar melting vessel and add active ingredients & other excipients.
  • Mixed it by stirrer and high speed homogenizer with heating
  • Then leave it for cooling purpose with continuous stirring.
  • Filter it and transfer it to storage tank (With Stirring).
  • Passed it through colloid mill for homogeneous mixing
  • Transfer it to floating tank of filling machine by transfer pump system.
  • Fill liquid into bottles of your choice i.e. 100 ml/200 ml/500 ml etc.
  • Place cap to the neck of bottle and sealed it.
  • Send sealed bottle for labeling and packaging purpose

 

Manufacturing of Solid Dosage Form i.e Tablet Manufacturing and Capsule Filling

In this article we will discuss about manufacturing process. Documentations, Requirements and other formalities to start solid dosage form is similar as starting manufacturing company

Solid Dosage form is well accepted and most popular doasge form in pharmaceutical industry. Accuracy in dose and easy to take like advantage give it popularity among professionals and patients. Today we are going to discuss about manufacturing of solid dosage form i.e. Tablet and Capsule.

Technical Staff:

Non Technical Staff:

  • Machine Operators
  • Helpers

Section Required:

  • Mixing, Granulation and Drying Section
  • Tablet Punching Section
  • Coating (Film Coating and Sugar Coating) Section
  • Capsule Filling Section (In case of Capsule)
  • Packaging Section

Machinery used:

  • Weighing Machines and Testing Equipments ( E.g. Electronic Balance, Hardness tester, Friability and Disintegrated Test Apparatus, tablet inspection units, Dissolution test apparatus etc)
  • Disintegrator and Shifter
  • Mixer (Mass/Rapid/Planetary Mixer)
  • Granulator
  • Drier (Trey/Fluid Bed Drier)
  • Rotatory (Tablet Compression Machine) – Single or Multi Punch
  • Punches and Dies (As per tablet Size/s)
  • Packaging machines (Blister/Strip/Alu-alu etc) and Testing Equipments
  • Coating and Polishing Pan (In case of Coated Tablets)
  • Capsule Filling Machine

Tablet Manufacturing:

Tablet manufacturing Process involves following steps:
  • Dispensing of Ingredients
  • Sizing
  • Blending
  • Formulation
  • Milling & Granulation
  • Drying
  • Final Blending:
  • Tablet Compression
  • Coating
  • Packaging

 

Three Processes are used to manufacture tablet dosage form:

  • Direct Compression
  • Wet Granulating
  • Dry Granulating

Direct Compression Method: This method is used for tablet compression only if powder/s is easily compressible and doesn’t require any additional requirement for compression. All powders are mixed and directly compressed into tablet punching machine for making a tablet. Powdered should be blended together and should remain in mixed form.

Wet Granulating Method: Widely used method for making tablets. If powders used are not easily compressible or floppy in nature or don’t mix well then wet granulating process is used. Wet granulating method follows following steps:

  • Mixing of active ingredients and excipients
  • Preparation of binding material
  • Addition or mixing of mixed powders and binding solution
  • Sieved or milled to convert into granules
  • Drying and Sieve again
  • Mix disintegrant, glidant and lubricant in to it

Dry Granulating Method: If the material used is sensitive to heat or volatile in nature then we have to compress tablet without use of heat and solvents. There are two basic procedures used in dry granulating method. One is to form a pack or compact by compression and then sieved or milled to convert into granules. In dry granulation, one method is to recompress powder into slugs and milled to form granules and second method is to form compacts through pressure. Compaction of powder is accomplished by rolling powder under pressure.

Method used for manufacturing tablet is depended at raw material nature used for making tablets. Wet Granulating Method is widely accepted and used to compress raw material into tablet form.

A tablet contains many ingredients other than active ingredient/s to manufacture a good quality tablet. These ingredients are known as Excipients. These excipients are in-active and neutral in nature and don’t have any medicinal property so don’t show any effect or side effect in body. Quantity and nature of active ingredients vary product to product and manufacturing method to method. A particular formula is prepared and keeps safe for future purpose for conversion of a particular active ingredient into tablet form. This formula contains adequate quantity of excipients to be added to smoothly convert a molecule into tablet form. This formula is known as Master Formuls Record. Whole manufacturing process is noted down in a record known as Batch Manufacturing Record (BMR). BMR is prepared batch wise and has to keep at safe place for future reference. A Particular number is provided to a Batch for maintaining record and samples known as Batch Number. BMR record should be duly maintained and signed by authorized person (Supervisor or Manufacturing Chemist). At every step of manufacturing, quality assurance team will inspect whole process and will check for quality & accuracy purpose. Quality Control section test for accuracy of all parameters as per reference book.

Procedure for Tablet manufacturing:

  • Dispensing: Each ingredient including active ingredient/s should be accurately dispenses as per dose. It is one of the critical steps any type of formulation. Weighing and measuring should be done under technical supervision.
  • Sizing: If all ingredients are of equal size, it becomes easier to mix all of them. Sizing is an important part in tablet manufacturing. Reduce all ingredients to equal size for better flow property and easy mixing.
  • Blending: Blend all powders to make a uniform and homogeneous mixer.
  • Formulation: Mix this mixture with binding agent.
  • Milling: Now above formulation passed through mills or sieves to form granules.
  • Drying: Granules need to be dried for a particular time period in trey dry or fluid bed drier.
  • Milling: Again pass through this mixture into mills and sieve it.
  • Final Blending: Blend above granules finally with disintegrants, Lubricates and glidants.
  • Rotary Machine: Next step is to compress these granules into Tablet Form. Rotary machine contains punch and die. Size and shape of punch and die may vary according to your need. Compression is crucial for tablet manufacturing. It should not be low or high. If it will be low, tablet will not have hardness. If compression is high then tablet dissolution time will be affected. Granules or powder is flowed toward dye; fill the space obtained by vacuum in die. After filling of die, punch compression is obtained to convert powder or granules into tablet.
  • Coating Pan: If tablets need to be coated then a coating material is prepared and sprayed at tablets in coating pan till desired coating film is obtained.
  • Packaging: Now tablets are packed into pre-defined packaging material.

Tablets Defects that should be consider during Manufacturing:

  • Weight Variation
  • Friability Variation
  • Capping and Molting
  • Sticking and Picking
  • Laminating
  • Double Press
  • Chipping

Test during and after Manufacturing:

  • Weight Variation
  • Hardness
  • Dissolution Time
  • Friability Testing
  • Assay

Why Granules is more beneficial than powder form:

  • Improve powder flow property and create uniformity in dosage form
  • Improve Compressibility
  • Reduce fineness
  • Control Powder tendency to segregates
  • Control Density

Disadvantage of Powder Forms:

  • Poor Flow Property
  • Capping and Laminating Property
  • Don’t mix well
  • Dust Formation
  • Difficult to handle

Hard Gelating Capsule Filling Process:

Few steps of capsule filling process are same as Tablet manufacturing process. Powder has many disadvantages as compare to granules, so in capsules filling we require granules or pallets (about pallets we will discuss in other articles) but powder is also filled into capsule body. Till Granulation, whole process is same as in case of tablet manufacturing process. Temperature, moisture and humidity of area where capsule is going to be filled should be controlled with the help of air conditioner and de-humidifier. Capsule shell is sensitive to moisture and heat. So handle it with caution.

Principles of Capsule Filling Machines:

  • Positioned all incoming capsules into upright position
  • Separate Cap and Body of Capsule Shell
  • Attained Pre-determined Volume
  • Fill powder/granules/pallets in Capsule shell body
  • Remove excess material
  • Rejoined Cap and Body of Capsule Shell
  • Eject capsule from machine
  • Polishing of capsule shell
  • Packaging
Preparation for Filling Hard Gelatin Capsules: At large scale and small scale generally filling of capsule could be divided into following steps:
  • Developing and preparing the formulation and selecting the capsule size
  • Filling the capsule shells
  • Capsule sealing (optional)
  • Cleaning and polishing the filled capsules

 

Types of Capsule Filling Machines:

  • Hand Operated Capsule Filling Machine
  • Semi-Automatic Capsule Filling Machine
  • Automatic Capsule filling Machine

Hand Operated Capsule Filling Machine:
An operator is required to handle whole process manually. Operated is required to organize capsules in correct position and fill in tray having 200 to 300 holes and placed at bed having same holes. Separate caps from body with the help of cam handle, accurately positioned powder tray to fill body with drug, use pin tray to press filled powder and fill more powder for accurate dose, remove powder tray after complete filling. Replace cap handling tray and operate handle to re-joined capsule shell, remove loading tray and collect filed capsules. Approximately forty thousand to sixty thousand capsules can be filled in eight hour shift.
Hand operated machine is consisted of bed having holes and cap handling tray, a loading tray, A powder Tray, A pin Plate, A sealing plate having rubber top, A lever, A cam Handle.

Semi Automatic Capsule Filling Machine: In semi automatic capsule filling machine, operator require to move rings (Capsule holder rings) from rectifier to the filling and closing section. Production capacity of semi-automatic capsule could be 25000 capsules per hour which is two lakh capsule in eight hour shift.

Automatic Capsule Filling Machine:Automatic machine are divided into two categories: Continuous and Intermittent operations. In Intermittent operation, machine is divided into two segments. Each segment indexes from each machine function; rectifying, fill, tamp, close and eject. In continuous operation, machine is work continuously from capsule pouring to capsule filling.

Hope above information is useful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How to Register Ayurvedic Products before Launching in Market?

Query:

My Name is ———- and I have been researching on ayurvedic medicines from last two years. I have come up with a solution for problem related to stress, low energy, low libido in men. I want to manufacture this product and sell this product in market. I have been told that one needs clinical trails at government hospital to get the drug manufacturing licence. Can you please help me here, following are the areas i need help.
1) Is it true that without government clinical trails you can’t get drug manufacturing licence?
2)if yes then how do i get these clinical trails done.
3) My product is very simple in nature it few roots dried and mixed together, there no chemical and no other compound it totally plant based. I want to start on small scale and gradually grow. How do I meet the requirements of machinery in drug licence.
4) I can even make these medicines from home can I sell like this?
5) How do the get the required technical staff on board as required for drug manufacturing licence.

Kindly help me with this. thanks a lot



Response:

There is certain formalities to manufacture ayurvedic products.

1) You will not need for any clinical trial report for ayurvedic medicine to get approval from ayush department of concern state. You just need to fulfill medicine detail with herbs, quantity with reference book etc. Read: How to Register Ayurvedic Products before Launching in Market?
2) N/A
3) Most of ayurvedic products is manufactured by using herbs or plant parts. If you want to sell it as a Ayurvedic Medicine, you will need to take Ayurvedic Manufacturing License. Read complete procedure for Ayurvedic Manufacturing License Here
4) You can’t manufacture any ayurvedic medicines at home for commercial use except in some conditions. You can get manufactured these products from other manufacturers at third party manufacturing basis.
5) You have to hire technical staff i.e. manufacturing chemist and analytical chemist. Certain Job placement agencies can help in finding staff for you.

Hope Above information is useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com