Pharmaceutical Manufacturer

Companies or Firms who are engaged into manufacturing of finished pharmaceutical formulations (Drugs and Medicines) are known as pharmaceutical manufacturers.

Manufacturing of pharmaceutical finished formulations are regulated through Drug and Cosmetic Act & Rules. No firm or company can manufacture pharmaceutical products without taking manufacturing license from licensing authority appointed by drug department. For taking manufacturing license for pharmaceutical products manufacturing, a firm or company has to compile with the standards and requirements specified in Schedule M of Drug and Cosmetic Act & Rules.

According to Drug and Cosmetic Act & Rules, Manufacture process is defined as ‘manufacture in relation to any drug or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business; and to manufacture shall be construed accordingly;

Along with manufacturing license, pharmaceutical manufacturers have to take approval of medicine or drug, they wants to manufacture under their manufacturing unit. Pharmaceutical manufacturing license is granted by licensing authority appoint by concerned state food and drug administration. Pharmaceutical manufacturer also require having wholesale drug license to sell and stock finished formulations.

For applying medicine manufacturing license, manufacturer should have minimum of following requirements:
  • Plant and premises fulfilled WHO: GMP guideline or Schedule M guidelines.
  • Technical Persons (Manufacturing Chemist and Analytical Chemist)
  • Machinery and Equipments
  • Section wise partition
  • HVAC Unit
  • Workers and Supervisors
  • List of medicines to be manufactured
  • NOC from required departments whichever applicable like pollution board, health department, MC Etc.
  • Registration of Factory under Factory Act if applicable

A pharmaceutical manufacturer may deal in one or more dosage form depends at area and capacity of premises and plant. Different type of dosage form includes: Topical/External, liquid, solid, ophthalmic, parenteral etc.

Read: How to start pharmaceutical manufacturing unit?

A pharmaceutical manufacturer can conduct business in following ways:

Hope Above information is helpful to you...
For any query and suggestion mail us at pharmafranchiseehelp@gmail.com

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