How to start Pharmaceutical Manufacturing Unit in South Africa?

In this post, we will discuss about how to start Pharmaceutical Manufacturing Unit in South Africa. Topics Cover in this post are

  • Steps before Starting
  • Requirements
  • Sections
  • Procedure
  • Documents Required

Pharmaceutical Manufacturing Unit/Company Licensing and Registration is covered underĀ MEDICINES AND RELATED SUBSTANCES ACT, 1965. Medicines Control Council Handles all process related to registration and licensing in South Africa. Every medicine that are imported, exported, manufactured and distributed in South Africa should be registered at Registrar of council.

Steps before Starting Pharmaceutical Manufacturing Unit in South Africa:

  • Apply to the Council for a licence to manufacture, import or export, act as wholesaler or distribute medicines, Scheduled substances or medical devices
  • Appointment of a technical person such as a pharmacist who will supervise and control the manufacturing or distribution of medicines and related substances
  • Appointment of an authorized person who resides in the Republic and responsible for all activity related to licensing procedure and interaction with council
  • Premises as per Good Manufacturing Practice arrangement

Requirements:

Manufacturing Sections

A Medicine manufacturing unit can have one or more section depend at nature and types of product to be manufactured. There is requirement of separate section to manufacture a particular dosage form to prevent contamination and following cGMP requirement. Every dosage form requires different type of machinery and equipment for manufacturing and processing. Few sections that are required in pharmaceutical manufacturing unit are as follow:

Procedure for applying for Pharmaceutical Manufacturing Unit License:

  1. Applicant has to submit application to registrar on a prescribed form provided by council
  2. Registrar will issue a written notice to applicant regarding documents to be submitted to council for granting license to manufacture medicine and related substances in reasonable time
  3. Council will inspect the business premises specified in application
  4. If the council is satisfied with all requirements and arrangement, council will issue license to applicant for manufacturing of medicines and related substances

Documents Required:

  • Documents related to Business Ownership
  • Registration of the responsible Pharmacist
  • Qualification certificates of staff responsible to manufacture, store, distribute and sell medicines and related substances
  • Copy of Local Area Plan of location of the Business
  • Floor plan of building in which business is situated
  • Blue print of Building and Premises
  • List of Machinery and Equipments and Inventory for it
  • Site Master File indicating procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines and related substances
  • List of medicines and related substances to be manufactured
  • Application and Inspection Fee Receipt

Hope Above information is helpful to you…

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

Related Post: How to start medicine distribution business in South Africa?

List of Pharmaceutical Companies in South Africa.

How to Start Pharmaceutical Manufacturing Unit in Pakistan?

Procedure for Grant of Drugs Manufacturing License in Pakistan

In this article, we will discuss about how to start Pharmaceutical Manufacturing Unit in Pakistan. The Drugs Act, 1976 of Pakistan regulates the import, export, manufacture, storage, distribution and sale drugs in Pakistan. The grant of licenses to manufacture drugs is regulated by Central Licensing Board (CLB) setup under section 5 of the Drugs Act, 1976.

The Central Licensing Board (CLB) comprises of desired members including experts from the fields of Manufacturing and Quality Control of Pharmaceuticals, Professors of renowned universities, representatives of Health Departments Government of Punjab, Sindh, Khyber Pakhtun Khwa, Balochistan and a Law expert.

Procedures and Requirements may be change with change in Rules and Regulations as per Government of Pakistan.

Types of Licenses:

  • License to manufacture by way of Formulation
  • License to manufacture by way of Basic Manufacture
  • License to manufacture by way of Semi Basic Manufacture
  • License to manufacture by way of Repacking
  • License to manufacture by way of Experimental purpose

A pharmaceutical manufacturing unit (facility) can possess more than one licenses depending upon the nature of activity being under taken by the manufacturer / licensee

Requirements:

Manufacturing Sections

A Pharmaceutical Manufacturing Unit is used to manufactured different dosage form. Different dosage form manufacturing requires different machinery and different sections for preventing contamination and following GMP protocols. Few sections that are required in pharmaceutical manufacturing unit is as follow:

Documents for manufacturing License:

  • Application on Prescribed Form-1
  • Fee Challan Copy
  • Legal Status of firm (For proprietorship firm: – name and address of proprietor, for partnership firm: – name and addresses of partners, for company: – name and address of company and directors)
  • Premises details including layout plan of the factory
  • Section-wise equipment and machineries details for manufacture and quality control
  • Qualification and training of Production-in-charge and Quality-in-Charge, and other technical staff for manufacturing and quality control department
  • List of drugs to be manufactured including name, class/es of drugs and dosage form/s of the drug

Procedure for granting of Pharmaceutical Manufacturing License in Pakistan:

The salient features of the procedure for grant of a license by way of formulation / basic/ semi basic/ re-packing are as under: –

  • First submit an application Central Licensing Board for establishment of a pharmaceutical unit.
  • Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application.
  • Filed Officer will recommend or reject for establishment of pharmaceutical unit as per requirements under Schedule B of the Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under the Drugs Act, 1976
  • Application will be processed to competent authority for site approval.
  • Competent authority will communicate with applicant if site is compile with provisions of rule otherwise application will be rejected.
  • For approved site, applicant is required to submit layout plan, drawn inline with cGMP requirements etc.
  • If layout plan is found as per cGMP requirement, the same is processed for the approval of competent authority. The approval is communicated to the applicant for construction of the facility.
  • After complete construction of unit, applicant has to submit application for grant of Drug Manufacturing License (DML) on prescribed Form-1 along with necessary documents.
  • If application is fulfill all formalities then inspection is carried out by constituted panel.
  • If inspection is found to be as per rules and regulations, constituted panel will placed report before CLB in its meeting.
  • After that CLB passes its order on the recommendations of the panel report.
  • License at Form-2 will be issued in case of approval of Drug Manufacturing License for five years which is subject to renewal further such time period till suspended and/or surrendered.
  • The procedural requirements for other types of Drug Manufacturing Licenses are similar as that of the Formulation, with some variations of conditions depending upon the type of the license.

Related: List of Pharmaceutical Companies in Pakistan

How to A Start Pharma Manufacturing Company?

Query:

I registered the own Pharmaceutical company 2015 and I am willing to start manufacturing , under own brand new what is the procedure and how much investment required. 
1) How much area required to start manufacturing company and also investment? 
2) What kinds of drugs need to manufacturing I am interested in Anti-Diabetic, Anti-TB and Anti-Cancer. 
3). Minimum from how many product I can start manufacturing dose I need all kinds of products such as injections, formulation and API. 
4) How many days required to get the license for product for manufacturing. 
5) can I export them to over seas if I am having suitable market at overseas? 
6) Can I start Pharma Marketing company under the same roof? or need to registered other company?
7) No of staff required for the Company. 
8) Can I do the third party manufacturing for other or outsource my projects. Thanks

Response:

1. Area required to start manufacturing company and approximate investment, you can read at our article: Pharmaceutical Manufacturing Unit Project

2. You can manufacture any type of drugs which you will get approval from drug department. You will have to provide list of molecules you want to manufacture along with your drug license file. Check list of document for pharmaceutical manufacturing unit

3. There is different requirements for different type of products. Simple tablet/capsule plant will require different requirements where as injection plant will require total sterilized and aseptic conditions. API will require different requirements. You will need different plants or premises/floor for staring these three things.

4. Time required is dependent at time you complete all necessary requirements for getting approval from drug control office. If there is no objection at your file, you will get manufacturing license after inspection of your plant by drug control officer.

5. If you fulfill all requirement as per exporting country, you can export to any country. Read in detail about Export of pharmaceutical Products

6. You have to separate your marketing company premises from manufacturing company premises.

7. Staff depend at your work load other than authorized staff like manufacturing chemist and analytical chemist.

8. You can do third party manufacturing from your unit. Read at complete about third party manufacturing here

Hope this information will be helpful to you…

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

Can I establish pharmaceutical manufacturing company after MBBS?

Query:
Sir please send information. Can I establish pharmaceutical manufacturing company after MBBS? Along with procedure and minimum budget?
Response:

You have to fulfill all requirements as we discussed in our article: How to start pharma manufacturing Unit?

Your Qualification is not concern about pharmaceutical manufacturing company. You will have need of one manufacturing chemist and one analytical chemist to start pharma company.

Procedure read in above link and about minimum budget read in our article: Pharmaceutical Manufacturing unit Project Report:

How to start Pharma Manufacturing Company?

Query:
I am perusing in b.pharma final year and I want to start an manufacturing plant with my Seniors and my batch mates. Is this a good idea. What are the requirements and investment it required for 2-3 products. 

Response:

Investment will be same for manufacturing unit whether you manufacture one product or large number of products. We always recommend B. Pharma Student to get some experience in industry before going into manufacturing business. We are pasting similar query related to your query.

We also recommend you to take minimum of two year experience in industry before going into manufacturing. All formalities regarding starting pharma manufacturing read here

You can also read our article:

Business plan for pharmaceutical manufacturing company

Starting Small Manufacturing unit for Medicine

Query:

I am Starting Small Manufacturing unit for Medicine. So Please advice me.
Response:
For starting Pharmaceutical unit, read requirements here:

How to start Pharma Manufacturing Unit?

What is the requirements and Challenges one has to face to start Pharmaceutical Manufacturing Unit?

What is third party/contract manufacturing in Pharmaceutical/Ayurvedic sector? Procedure, Requirements

How to expand your Pcd/Franchise/Third Party Business in Pharmaceutical Sector?

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

What is the best procedure to start pharma Company?

Query:

I want to start a pharmaceutical marketing company ,I gone through your website and got so many ideas but please do me a favour ,give me a brief idea according to my plan..like

I want to start the company with 10 products .so how much space i need initially for office and should I need C&F also ,Ideally how many employee i need to hired and overall how much budget will come .

Please just explain me everything ,what is the best procedure according to you.

Response:

Space will be same whether you start with ten products or single products i.e. 10 sq. meter. This space is required for drug license number approval. For office purpose you can use any attached room or space. Office space is as per your requirement. Read complete Documentation here.

We don’t think, you need any c&f in starting. You can directly supply to distributors. You will need a Pharmacist or EP in case you are not a eligible person, otherwise you can handle all things in starting if you have fund problem. Read: How much investment required to start pharma company?

Budget is directly proportional with molecules you select. Without this it is very difficult to give proper budget estimate. Documentation or administration you can suppose to nearly seventy thousand approximate.

Best procedure is to start slowly and without any pressure at mind & start it freely. Clear all you doubt before going into entrepreneurship.

Read below articles related to your query:

How to calculate MRP, PTS and PTR ?
What is third party manufacturing and how to get manufactured own brand name product ?
Other business opportunities available in Pharma Sector

Whether to start pharma wholesale or Pharmaceutical Manufacturing.

Query:
Currently I am employee in one third party manufacturing from last 4 years.
Now I want to start my own business.
But I am confuse whether I have to go in Pharma Manufacturer or wholesaler.
I have my own place more than 10 sq meter in Mumbai ghatkopar region for wholesaler & also I have my own place in pune ambegaon to start manufacturing contacts.
Also I have good contacts with big companies to work third party.
So pleases suggest me whether i want go in Pharma Manufacturer or wholesaler.
Response:

You can do one thing easily, you can start wholesale firm and take third party orders from other companies and get manufactured from some others. Supply material by fixing certain margin of yours in between.

If you have good contacts with companies who can give you third party orders and you can set-up own pharma manufacturing unit. Then you can start own manufacturing.

For other business opportunities in Pharma Read: Pharma Business Opportunities in India

Hope above information was useful to you…

Which one is better – Pharma Marketing Company or Pharma Manufacturing Company?

Query:
I am a MBBS student. I want to open a pharmaceutical company, so please guide me about its procedure, investment and challenges. Also tell difference between pharmaceutical marketing and manufacturing company and which one better suits a beginner.
Response:
Procedure for both type read below by click at link:

  • Pharma Marketing Company
  • Pharma Manufacturing Company

For investment, you can read our article: How much investment is required to start pharma company?

Main challenge that you will face is the establishment of your company. Establishing new start-up is more difficult as it seems. Other challenges are: Where to sell, How to sell, how to sustain sale etc.

In marketing company, Company get manufactured its brands from other manufacturing company and sell it but in pharmaceutical manufacturing company, company manufacture its own products and market them.

For beginners, marketing company is best suitable. It is less investment and expensive work as compare to manufacturing company.

Hope above information was useful to you…

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

Pharmaceutical manufacturing company in small budget

Query:
I want establish a pharmaceutical manufacturing company in small budget as soon as possible so, kindly guide the right path to me.

Response:


Pharmaceutical manufacturing company can be started with investment vary depend at sections. Liquid/syrup section can be started with low investment whereas parenteral plant is high investment plant.

You can choose section in your pharmaceutical manufacturing plant depend at your investment. Read Documents and procedure required to start pharma manufacturing company

Sales and marketing plays a vital role in establishing any company. You should have adequate orders as per your plant capacity for smooth running of you business. Sale can be generated by manufacturing at third party basis or by selling own brand name products.

For establishing manufacturing with small budget start with single section e.g. only liquid manufacturing company or only tablet manufacturing or capsule or powder or any other single section. When you will feel one section is running smoothly, then add another section. Single section requires less area and less machinery & staff etc. It also require less investment. Area required for starting pharmaceutical manufacturing read here.


If you have very less investment money, starting with food and dietary supplement company is not bad idea. Nutraceuticals like vitamins, minerals, calcium, iron etc has huge demand in market. Food and dietary supplement company requires less investment and few requirements as compare to pharma manufacturing unit. After establishing your food manufacturing unit, you can start with medicine manufacturing.

Food manufacturing unit will also give you own manufacturing unit experience with less headache because ot requires very less regulations and requirements to start and run.

Hope above information was useful to you

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