Directory of Peptide API Manufacturing Plants

Sinopep-Allsino Biopharmaceutical is a global commercial API provider and full-service CDMO focused on end-to-end CMC development and commercial production of peptides, oligonucleotides and small molecule APIs. Serving global innovative pharmaceutical companies since 2009, it has passed four US FDA inspections and strictly follows FDA and ich guidelines. The peptide production capacity reaches 20–30 metric tons per year; a large-scale GMP oligonucleotide base has been built in Lianyungang, Jiangsu Province (annual output can reach thousands of kilograms, containing ASO, siRNA, GalNAc, AOC, liposomes and other conjugates). Services cover polypeptide/oligonucleotide CDMO, FTE, discovery services, generic APIs and preparations (oral solid preparations, lyophilized powder injections, etc.), providing process development, analytical method development and validation, stability research, and IND/NDA regulatory support to achieve a seamless connection from early development to commercial supply.

Teide Pharmaceutical (Zhejiang) Co., Ltd. (stock code 03880.HK) is a contract research, development and production organization (CRDMO) specializing in polypeptides, providing full-cycle services from early discovery, pre-clinical, clinical development to commercial production. Headquartered in Hangzhou, China, it has commercial production bases and offices in China and the United States, and has been deeply engaged in the field of polypeptides for more than 20 years. Provides CRO (polypeptide new chemical molecular entity discovery synthesis) and CDMO (polypeptide CMC development and commercial production) services, and has extended to oligonucleotide CDMO since 2021. It has provided more than 1,000 customers worldwide with support for the synthesis, development, production and CMC declaration of polypeptides that meet the regulatory requirements of major markets around the world. The project covers more than 50 countries such as China, the United States, Japan, Europe, South Korea and Australia. Clients include large pharmaceutical companies, biotech companies, virtual pharmaceuticals and start-ups. The peptide biochemical tirpopeptide drug substance in the subsidiary has completed the US FDA DMF registration.

Founded in 2000, Suzhou Tianma Pharmaceutical Group Tianji Biopharmaceutical Co., Ltd. is a high-tech enterprise and enterprise technology center in Jiangsu Province. The company's new industrial base has been completed and put into operation in Jiangsu Changshu New Material Industrial Park. It is planned to be built according to the high standards of the pharmaceutical industry at home and abroad, and is the core carrier for the integration of polypeptide and small molecule drug research and development and commercial production. Representative peptide/polypeptide preparation products include: cortisol ® terlipressin for injection, Amgas ® octreotide acetate injection, Anqi ® carbetocin injection, lidine ® thymus method for injection, etc. The base can meet the needs of capacity upgrades and business development, and provide reliable products and professional technology solutions for domestic and foreign pharmaceutical partners. (Note: Group subordinates contain a small amount of non-pharmaceutical sectors such as hotels, etc., which have been omitted.)

Sichuan Tongsheng Biomedical Co., Ltd. (founded in 2011, Deyang) is committed to providing key starting materials (KSM) and intermediates for polypeptide drugs and chemical drugs. The products cover the screening, small trials, pilot trials to commercial production services of key materials for clinical new drugs, including polypeptide drugs KSM, Fmoc-amino acids, unnatural amino acids, polypeptide side chains, short peptides, and small molecular drugs KSM, Boc-amino acids, amino acid derivatives, and heterocyclic pharmaceutical intermediates. The company has a number of 50-5000L reactor multi-functional production lines (grams to 100 tons), R&D team of 30 people (including 2 doctorate, 6 master's), QC/QA of nearly 30 people; currently planning to build about 65 acres of new base (including GMP workshop, three multi-functional workshop and peptide protection amino acid line workshop), has provided custom synthesis services for the world's leading pharmaceutical companies, CDMO and API companies.

Suzhou Nike Tai Biotechnology Co., Ltd. (Suzhou) is an innovative biotechnology enterprise focusing on innovative research and development and customized production of polypeptides. Relying on advanced synthetic technology platform and strict quality management system, it provides high-purity, high-quality polypeptide raw materials and integrated solutions from milligrams to kilograms in the fields of medicine, skin care and health. The main business covers peptides/cosmetic peptides/pharmaceutical peptides: the field of peptide raw materials provides bioactive peptides (scientific research, diagnostics, pharmaceutical intermediates); cosmetic peptides focus on active peptides such as anti-aging, repair, and firming; pharmaceutical peptides focus on research and development and process development of highly difficult pharmaceutical peptides, providing innovative drug and generic drug companies with one-stop CMC services from preclinical to commercialization. Equipped with a modern R&D center and GMP-compliant production facilities, we aim to be a reliable partner in the field of peptide technology.

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.

Qingdao Sigma Chemical Co., Ltd.) mainly develops, manufactures and sells pharmaceutical raw materials, chemical intermediates, biochemicals, veterinary drugs and nutritional products, with synthetic capacity ranging from grams to tons, and provides custom synthesis and contract production (CMO). Peptides are one of its product lines. The official website lists GHRP-6, CJC-1295, Melanotan, HGH Frag 176-191, Ipamorelin, Hexarelin, PT-141 and other peptide raw materials, and claims to have a professional production quality control team, domestic and foreign warehousing and global shipping channels.