Third party manufacturing is easy way to get manufactured product at your brand name. Read complete about pharma third party manufacturing here
Third party manufacturing process includes:
You have to do below things and process by your self:
- Choosing Company name (marketed by address)
- Starting a pharma marketing Company
- Selection of molecules and compositions you want to get manufactured
- Choosing Brand Names for these compositions
- Company Registration (Optional)
- Trademark Registration of Brand Names (Optional)
- Finalizing design for packing material
- Choosing third party manufacturer
- Procurement of packaging material ( In case you are providing packaging material yourself)
- Choose manufacturer
- Send quotation
- Receive rate ( If possible bargain in rates)
- Contract third party agreement
- Send detail of your marketed by company, brand name etc( Scan copy of Drug License number and GST number)
- Send Final order
- Finalize design
- Deposit advance payment ( generally 25 to 30 % of final amount plus packaging material security)
- Product approval
- Packaging material availability
- Manufacturing process
- Finished goods
- Final payment deposit
- Product approval
- Procurement of packaging material, active ingredients, raw material etc.
- Manufacturing of product, packaging and dispatch
Option 1 Marketed By Pharma Franchise Help Karnal, Haryana - 132001 Manufactured by PFH Pharma Mumbai West -468605 Option 2 Marketed By Pharma Franchise Help Karnal, Haryana - 237506 Manufactured by Pharma Franchise Help Mumbai West -468605 Option 3 Marketed By PFH Pharma Karnal, Haryana - 237506 Manufactured by A leading Brand of PFH Pharma
Which one is correct or we can choose any one. Is there any rule (Reference) for this, in Drug and cosmetic act & rules.
If you are marketing company and getting product through third party manufacturing then Option 1 will be applicable along drug manufacturing license number of manufacturer:
Your Company Name
and manufactured by address is also compulsory
manufacturing company name address
I am attaching a sample of my product for your reference. Image is of Ayurvedic product but same is applicable for pharma products.
Option 2 will be applicable in case if manufactured by and marketed by company is same but have manufacturing unit at different place and marketed office at other place….
Option 3 can’t be applicable in pharma manufacturing because name and address of manufacturing unit is compulsory at pharma products.
Presently I do not have any designer for art work of packaging materiel, how can i will make it possible?
Manufacturer could provide you Design and artwork for your product. You only have to contract with manufacturer at rates inclusive of packaging material. He will take some security charge against packaging material for remaining packaging material. It generally 5000/- per product. Read more about packaging material procurement here
Also confirm what is the best % value of MRP, is consider as good deal for third party negotiation. Like my product MRP is INR 100/Bottle, so the best rate for third party is INR 25/Bottle including transportation and taxes.
Third party rate doesn’t depend at mrp. There is not any co-relation between mrp and third party manufacturing rates. Take quotation from 4-5 manufacturer and compare rates and services. This is one of way to find out best rates for your products. Fixing mrp is your choice if it doesn’t come under DPCO.
I checked and found some company is doing the option 2 printing on product even though both the companies are different. You can see the some products from — pharmaceuticals. I also seen the same. In Big Company ELZAC is using same mentioned (may be they get product from loan licence or contact manufacturing). In this label the Marketed by is Elzac Ltd Mumbai, and MFG by Elzac Ltd Sikkim. As there Marketing office in Mumbai and MFG location in sikkim (Kumrek, Rangpo). But they get product from ELZ Pharma (Majhitar, Sikkim). So write on product MFG By ELZAC LTD, Majhitar Sikkim, and MKT by ELZAC LTD, Mumbai. How they are doing. Can you give some reference guideline for labeling content of Third party/loan licence/Contact manufacturing. Like Indian FDA rules or drug and cosmetic rule.
As you mention a case of option 2, it comes under loan license. You have to get manufactured your product at loan license basis. In loan license cases, all things like packaging material, raw material, excipients etc is given by marketed by company and only processed by manufacturing company. Marketing company can send its representative also for taking care of all manufacturing activities. Batch manufacturing Record, quality reports etc will be filled with name of marketing company. Its like renting of machinery and plant of any manufacturing unit to boost up manufacturing process of own products. Only address of manufacturing firm will be written and manufactured company name could be of marketing company. Marketing company give some commission or percentage of margin like 2-3-5/- per box etc to manufacturing unit for using its plant for their product. It requires lot of documentation and formalities.
This process is different from third party manufacturing process.
Guideline for labeling:
Before a drug is sold or distributed in India, it must be labeled according to specifications outlined in the Drugs Rules. The Drugs Rules specify labeling standards for non-homeopathic (Part IX), homeopathic drugs (Part IX-A) and biological and other special products (Part X). The ‘Scheduled’ drugs under the Drugs Act are required to indicate the particular drug’s Schedule and must specify the required warnings and additional requirements per the Act. In respect of non-homeopathic drugs, the Drugs Act prescribes the pack sizes of drugs meant for retail sale, the contents of the label such as name of the drug, statement as to the net contents (in terms of weight, measure, volume), the contents of the active ingredient, license number, dates of manufacture, expiry, whether the medicine is for external or internal use, whether it is for human use or animal use, the name and address of the manufacturer and the address of the premises where the drug has been manufactured, the batch number, as well as the drug license number under which it is manufactured (if manufactured in India or elsewhere). Imported products must display the expiration date and potency of the active ingredient in addition to the import license number. The Standards of Weights and Measures Act, 1976 and the Packaged Commodities Rules, 1977 provide additional labeling requirements.
Can You guide me from where I can get information whether this product is comes under DPCO or not? As I am interest to do business in allopathic.
I am also interested to do business for medical devices import from China.
I got the information from supplier also and he can deliver the material in any port of India. From there how can I bring materials to my address. What is custom rules and how to get clear it. Is there any agent/agency is available to help in this matters.
DPCO list is available at National Pharmaceutical Pricing Authority website: http://www.nppaindia.nic.in . You have to read notification regularly for updates in whats new segment. Or manufacturer will have complete list. He will provide you all details.
Hope this will be helpful for you. For further queries, correction and suggestions, mail us at email@example.com
- What is third party/contract manufacturing in Pharmaceutical/Ayurvedic sector? Procedure, Requirements, Inventory !
- What is the procedure for packing material Procurement, Inventory, type in Pharmaceutical/Ayurvedic Manufacturing Company?
- How to ensure quality of products in third/contract manufacturing?
- What is the Minimum Order Quantity (MOQ) for third party manufacturing?