Loan License and Third-Party Pharmaceutical Manufacturing in Pune: Form 25A & 28A FDA Guidelines

Contract Manufacturing: Pharmaceutical Loan Licenses in Pune (Form 25A & 28A)

Pune and the surrounding industrial corridors of Kurkumbh, Chakan, and Shirwal form a major pharmaceutical formulation hub. For pharmaceutical marketing startups and brand owners who own proprietary drug formulations but lack multi-crore capital to construct an independent WHO-GMP certified manufacturing plant, the Drugs Rules provide an ideal legal vehicle: the Loan License framework on Form 25A and Form 28A.

Under a Loan License, the applicant utilizes the manufacturing facility, plant machinery, and testing laboratories of an established licensed manufacturer to produce medicines under their own commercial brand name. The loan licensee remains personally responsible for drug quality, batch stability testing, and regulatory compliance. KOKJAGUAR Consultancy helps pharmaceutical marketers draft third-party manufacturing agreements and secure FDA loan license endorsements. Discover our pharma manufacturing licensing services.

Key Requirements for Loan License Grant

• Manufacturing Agreement: Tripartite legal contract between the brand owner and the parent factory owner defining batch allocations.
• Parent Facility Capacity Certificate: Certificate from the parent factory verifying surplus production capacity without compromising existing commitments.
• Approved Testing Laboratory: Formal access to in-house or approved external testing labs for raw material and finished product assays.
• Competent Technical Staff: Appointment of qualified approved Manufacturing and Analytical Chemists.