I want to start a pharma company with third party loan license. pls advise me the procedure
First you have to understand difference between loan license and third party manufacturing. These are two resemble terms but both have minor difference in nature.
Loan License: Under Drugs and Cosmetics Rules, A Loan license is defined as “For the purpose of this rule a loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in form 25 or in form 28 as the case may be.”
Third Manufacturing/Contract Manufacturing: When a firm/company (marketing/manufacturing firm/company), called party ‘A’ enters into an agreement with the manufacturing firm/company, called party ‘B’ and Party ’B’ agrees to manufactured generic/patent-proprietary product of party ‘A’ in the manufacturing facility belonging to Party ‘B’ on bases of party ‘A’ wholesale drug license. Majority of Pharma marketing companies are engaged in third party manufacturing.
First you have to finalize whether you want to manufacturer at loan license or third party basis. This is not matter of doubt. This is only for informational purpose.
Procedure is almost same for both above process. In first one manufacturer will apply to drug authority on behalf of you to manufacture your product at loan license. This is somewhat complicated process. Third party and contract manufacturing is popular and easy process.
You can easily get your brands manufactured at low rates and small quantities. You are newly starting your company, so you will need small quantity in start. You should start with small quantity, after that when you feel, you can sell big quantity then get big batch manufactured.
Read more related to calculation: How to calculate Maximum Retail Price, price to retailer and price to stockist with any MRP?
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