Oxytocin is a nine-amino-acid hormone used to induce labour and control postpartum bleeding.
7 listed companies hold an active US Type II Drug Master File for Oxytocin API, based in China (3), India (2), Netherlands (1), Latvia (1). 7 have a regulator record of GMP manufacturing, and 1 carries an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Aspen Pharmacare's API site in Oss, Netherlands, with roots in 1923; makes peptides with a liquid-phase process plus hormones and heparin. Holds US DMFs for 4 peptide APIs.
Riga drug maker operating since 1946 that now offers CDMO services; WHO-inspected oxytocin API site; US DMF for oxytocin.
Indian CDMO whose Turbhe, Navi Mumbai site develops and makes peptide APIs by solid- and solution-phase synthesis. Holds US DMFs for 9 peptide APIs.
Chinese peptide drug manufacturer producing APIs and finished products.
Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.
Shenzhen peptide CDMO and API maker founded in 2009, with 13 cGMP lines and 85,000 L of SPPS/LPPS reactor volume. Holds US DMFs for 6 peptide APIs.
Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.
Companies holding active US DMFs for Oxytocin include Aspen Oss B.V. (Aspen API), JSC Grindeks, Piramal Pharma Ltd (Piramal Pharma Solutions), Hybio Pharmaceutical, Hemmo Pharmaceuticals Pvt Ltd (Piramal Pharma Solutions), Shenzhen JYMed Technology Co., Ltd. (JYMed Peptide) and Harbin Jixianglong Biotech Co., Ltd.. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (3), India (2), Netherlands (1), Latvia (1).
Harbin Jixianglong Biotech Co., Ltd. has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.