Directory of Peptide Formulation Plants

Shenzhen Han Yu Pharmaceutical Co., Ltd. (listed on the Shenzhen Stock Exchange, 300199, listed in 2011) is a national high-tech enterprise specializing in the R&D, production and sales of polypeptide drugs and small nucleic acids. Founded in 1998, it is an early listed polypeptide drug enterprise in China. The company has built a national and local joint engineering laboratory for polypeptide drugs, a national public experimental center for innovative polypeptide drugs, and a national pilot technology platform for the preparation of polypeptide drugs. It has undertaken a number of national-level projects and won the second prize of the National Technology Invention Award. It has passed the GMP/cGMP certification in China, the United States, the European Union, Brazil, Australia, South Korea and other countries, and has four major production bases: Shenzhen Pingshan Preparation Base, Wuhan Peptide Featured API Base (through the China/United States/Australia GMP certification, which is being expanded), Gansu Chengji Pharmaceutical Intermediates Base, Yunnan Dali Industrial Hemp Base, etc., to open up the whole chain control from raw materials to drugs. The APIs are sold to 20 + countries and regions, and the preparations are sold to 90 + countries and regions. The polypeptide products include GLP-1 injections such as liraglutide, smeclutide, tirpotide, etc., atoxiban, etibapeptide, etc., and have CRDMO (custom R&D + custom production) capabilities. The monomer reactor capacity is 100L-10000L.

Shenzhen Jianxiang Biotechnology (JYMed/Jianyuan Pharmaceutical) is a CDMO enterprise specializing in polypeptides, providing polypeptide API R&D and GMP production from milligrams to tons. With 13 cGMP production lines and 85,000 L spps/LPPS reactor volumes, the Hubei base has an annual production capacity of 10 + tons and has passed FDA, NMPA, and EDQM inspections. Employees of 650 + are located in Shenzhen (7,000 ㎡ R&D center), Hubei (52,000 ㎡ API production base, OEB-5 isolation), and Shenzhen (formulation FDF base). Services cover custom synthesis, polypeptide API manufacturing (long chain, unnatural amino acids, conjugates), cosmetics/veterinary drugs/health peptides and CDMO, supporting 1 g R&D to 100 kg commercial batches. With 20 + years of experience in peptide chemistry and CDMO, we provide peptide intermediates, APIs and CDMO services to pharmaceutical companies worldwide.

Sinopep-Allsino Biopharmaceutical is a global supplier of commercial grade APIs and a full range of polypeptide/oligonucleotide CDMOs. Providing end-to-end CMC development and cGMP production from early R&D to commercialization for new drugs (NCE) and innovative pharmaceutical companies since 2009. The company's current production capacity of polypeptides is about 20–30 tons/year. It has built a large-scale GMP oligonucleotide (ASO, siRNA and GalNAc, AOC, liposome and other conjugates) production facility that can produce thousands of kilograms per year in Lianyungang, Jiangsu Province. At the same time, it has small molecule generic drugs and NCE commercial production capacity. The quality and regulatory system is mature. It has passed four FDA on-site inspections, strictly follows FDA and ich guidelines, and provides process development, analytical method development and verification, stability research, and global IND/NDA declaration support.