Helping an American drugs manufacturer to select a contract manufacturing partner for producing generic drugs in India
About the Client
The client is an American Speciality Pharmaceutical Company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals, and active pharmaceutical ingredients.
The client was searching for a contract manufacturer in India to manufacture finished formulation in India One of the key aspect of selection was to identify companies that had the right certifications and approvals to meet the US standards.
TECNOVA’S APPROACH AND SOLUTION
Tecnova conducted the project in a phased manner with the first phase including identification of a list of companies that have US Food and Drugs Authority approved plants and a pipeline of generic products which were likely to go off patent in the near future. Other key criteria used for selection and due diligence included:
- Experience/capabilities in the various steps of synthesis for APIs and Formulations
- Experience of exports to regulated markets
- Accreditations and approvals
- Site or Facility performance
- Quality management (policy & standards)
- Quality control
- Regulatory experience with FDA
- Bio-study experience
- Safety/ Hygiene
- Environment (approvals from regulatory bodies)
- Capability to develop new generic products
- Production capacity to take on new products for exports
- Financial capabilities
Post due diligence the client, along with Tecnova team, met the shortlisted companies and visited their production facilities to finalize and close the deal.