Generic APIs

Sinopep is a trusted global supplier of high-quality peptide APIs intended solely for laboratory R&D, further manufacturing, or compounding by licensed pharmacies under applicable regulations (e.g., 21 U.S.C. § 353a/b and relevant state laws).
Our extensive portfolio includes dozens of generic peptide APIs supported by active Type II DMFs and four successful U.S. FDA inspections. These APIs are supplied as bulk drug substances only, are not finished pharmaceutical products, are not approved by the FDA for any therapeutic use, and carry no trademark rights or licenses from originator companies.
All marketing references are for identification purposes only and do not imply equivalence, endorsement, or authorization by brand owners. Partners are solely responsible for ensuring their use complies with current patent, trademark, and compounding regulations.

Sinopep is a trusted global supplier of high-quality peptide APIs intended solely for laboratory R&D, further manufacturing, or compounding by licensed pharmacies under applicable regulations (e.g., 21 U.S.C. § 353a/b and relevant state laws). With over two decades of expertise in peptide synthesis and manufacturing, Sinopep employs advanced hybrid solid-phase and liquid-phase technologies to produce complex peptides at scales ranging from grams to multi-kilogram batches, ensuring exceptional purity, consistency, and scalability. Our extensive portfolio encompasses a wide range of generic peptide APIs, supported by active Type II DMFs and a proven track record of four successful U.S. FDA inspections demonstrating unwavering commitment to regulatory excellence and quality standards. These APIs are bulk drug substances only, are not finished pharmaceutical products, are not approved by the FDA for any therapeutic use, and are provided without any implied licenses or authorizations. All marketing references are for identification purposes only and do not suggest equivalence, endorsement, or approval for clinical applications. Partners are solely responsible for ensuring their use complies with current regulatory, compounding, and intellectual property requirements.

Sinopep’s oligonucleotide technology platforms are equipped with state-of-the-art systems, including Cytiva OligoSynt/OligoPilot solid-phase synthesizers and AKTA Avant/Process purification equipment, enabling API production from milligram to kilogram scale. These platforms support comprehensive CRDMO services, covering the development and manufacturing of both drug substance and drug product from pre-clinical through clinical stages.