BioPharma Centrum Private Limited acts as a strategic partner for CDSCO registration, regulatory facilitation, and market entry support in India for both Active Pharmaceutical Ingredients (APIs) and Finished Dosage Formulations (FDFs). We support global pharmaceutical manufacturers, biotech companies, market authorization holders, and supply partners in navigating India’s regulatory framework through experienced regulatory associates and trusted local partnerships.
For overseas manufacturers seeking to introduce pharmaceutical products into India, understanding the regulatory pathway is critical. BioPharma Centrum helps bridge this gap by coordinating with regulatory experts and Indian partners to support smoother registration, documentation readiness, and commercialization planning.
Our support includes regulatory coordination for API registration, Finished Formulations (tablets, capsules, injectables, biologics, ophthalmics, topical products, etc.), import registration pathways, dossier coordination, manufacturer qualification, regulatory gap assessment, and commercialization support. We work closely with qualified partners to help ensure submission readiness aligned with CDSCO expectations.
For imported APIs and formulations, the process typically involves an Indian Authorized Agent (IAA) or importer coordinating with the overseas manufacturer for regulatory filings. A Form 9 undertaking is generally executed by the foreign manufacturer in favor of the Indian applicant/agent, authorizing representation and confirming compliance commitments for products intended for India. Following submission of the required documentation and regulatory review, Form 41 (Registration Certificate) may be issued for registration of the manufacturing site and products intended for import into India. After obtaining the required registration, the applicant may proceed toward an Import License under Form 10 (for applicable drugs), enabling commercial import into the Indian market.
While requirements may vary depending on product category, molecule type, country of origin, and regulatory classification, BioPharma Centrum supports partners in coordinating documentation, identifying regulatory pathways, and connecting with experienced specialists to help reduce delays and improve market readiness. Typical coordination areas include:
• Form 9 & Authorized Representation
• Form 41 Registration partner for APIs & FDFs
• Form 10 Import License registration partner
• Technical Dossier & Documentation Readiness
• Manufacturer Qualification & Indian Partner Identification
• Regulatory Gap Assessment & Compliance Review
• Commercialization, In-Licensing & Market Entry Strategy
With strong industry relationships and practical experience across pharmaceuticals and biotech, BioPharma Centrum serves as a dependable bridge between international manufacturers, Indian regulatory ecosystems, and commercialization partners, helping companies navigate the Indian pharmaceutical market with greater confidence and efficiency.