cGMP Production

High quality GMP synthesis has been a primary focus of Shengnuo Peptide since the company’s founding in 2001. During our more than 10 years of operation, Shengnuo has become a dominant solid-phase peptide manufacturer in the domestic Chinese market. This overwhelming success has led to the founding of our US-based sales team, which will bring our quality and expertise to the international marketplace.

Shengnuo’s GMP production group is made up of over 100 of the best chemists in China. These chemists are dedicated solely to GMP production and work in our more than 60,000 square foot cGMP facility. State-of-the-art instruments and infrastructure mean that our customers receive the highest possible quality and regulatory support. Customers select Shengnuo as their GMP manufacturing partner because of our intimate knowledge of regulatory guidelines in both China and the USA. Shengnuo has consistently undergone regulatory audits from the Chinese FDA (sFDA) since 2008 and, as of 2012, we passed a US FDA audit with no Form 483 observations. Having a firm grasp of the necessary quality and documentation rules in both China and the USA, makes Shengnuo an ideal global peptide partner.

A major benefit to working with Shengnuo Peptide for GMP projects is our ability to handle all parts of the GMP process: large single batch capacity, all necessary testing in-house (stability, microbiology, endotoxin, LC/MS, etc.), QC, QA and RA. Also, our regulatory team has assisted in several DMF’s (drug master files), CMC packages and drug registries.