Introduction & Background

The client is an American specialty pharmaceutical company engaged in developing, manufacturing, and marketing generic and proprietary pharmaceuticals, biopharmaceuticals, and active pharmaceutical ingredients. The client sought a contract manufacturer in India to produce finished formulations, with a key requirement being that the selected partner met US regulatory standards.

Objective: Identify and select a contract manufacturing partner in India with the necessary certifications and capabilities to meet US FDA standards.

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Tecnova’s Role

Phased Selection Approach

Conducted a detailed selection process in phases, starting with the identification of Indian companies with US FDA-approved plants and a portfolio of generic products that were expected to go off-patent soon.

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Key Criteria for Due Diligence

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• Evaluated companies based on their experience with APIs and formulation synthesis, export history to regulated markets, and relevant accreditations.
• Other factors considered included:
• Site and facility performance
• Quality management systems and standards
• Regulatory experience with the FDA
• Bio-study capabilities
• Safety, hygiene, and environmental approvals
• Capacity for developing new generics and handling increased production for exports
• Financial stability and capacity to support long-term partnerships

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Implementation Phase

-Conducted site visits and in-person meetings between the client and shortlisted companies.

-Finalized the deal with a partner that met all regulatory, quality, and operational requirements.

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Outcome

Tecnova successfully facilitated the selection of a contract manufacturing partner with FDA-approved facilities, ensuring compliance with US standards and enabling the client to efficiently produce generic drugs in India.

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Conclusion

Tecnova’s strategic support helped the client navigate the complex landscape of contract manufacturing in India, ensuring compliance, quality, and scalability for their generic drug production.

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