GMP Peptide Manufacturing Trusted by Global Innovators

Our GMP-compliant peptide manufacturing facilities operate under stringent quality systems designed to meet global regulatory expectations — including those of the United States, the European Union, and Japan.

Every GMP peptide is manufactured in accordance with ICH guidelines, with full traceability, validated processes, and a relentless focus on quality and consistency.

Our facilities have been inspected by the US FDA and other global regulatory authorities, and all GMP peptide products are supported by appropriate regulatory documentation, including Drug Master Files (DMFs).

Shilpa Medicare provides peptide contract development and manufacturing using solid-phase peptide synthesis (SPPS) and hybrid SPPS/LPPS approaches at its Raichur, Karnataka facilities, with in-house manufacture of protected amino acid derivatives and building blocks. A dedicated peptide manufacturing block under construction is intended to provide one of India's largest solid-phase synthesis capacities.

The dominant cost and supply risk in commercial peptide manufacture is not the coupling chemistry — it is the protected amino acid derivatives and specialised building blocks, which are concentrated among a small number of global suppliers and subject to significant price and allocation volatility. Shilpa Medicare manufactures key starting materials and side-chain building blocks in-house. For a GLP-1 or other commercial peptide programme, that converts an external dependency into an internal, controllable one.