Certification
PMDA-Approved CDMOs
Compare CDMOs with PMDA (Japan) GMP approval for manufacturing pharmaceuticals destined for the Japanese market. Filter by product type and manufacturing capabilities.
73 companies listed
About PMDA Approval
PMDA (Pharmaceuticals and Medical Devices Agency) is Japan's pharmaceutical regulatory agency. PMDA conducts GMP inspections of manufacturing facilities producing drugs for the Japanese market. PMDA GMP compliance is required for marketing authorization in Japan -- the world's third-largest pharmaceutical market by revenue.
PMDA inspections have unique characteristics. The agency places particular emphasis on change control (every manufacturing change must be formally assessed and approved), stability testing (Japanese climate conditions may require additional data), and data integrity. CDMOs with PMDA approval demonstrate compliance with one of the most thorough regulatory inspection regimes globally.
Companies (73)
CTX Life Sciences Pvt. Ltd.
India
CTX Life Sciences Pvt. Ltd. is a vertically integrated API and intermediate manufacturer based near Surat, Gujarat, India. The company operates a world-class manufacturing facility with a total area of 147,227 sqm, capable of handling complex and hazardous reactions, with DSIR-approved R&D and a collective reactor capacity of around 900 KL. The facility has been inspected by US FDA (6 times), EDQM, BfArM (Germany), TGA (Australia), PMDA (Japan), Health Canada, ANVISA (Brazil), and COFEPRIS (Mexico).
Small Molecule APIAnalytical ServicesMethod Development & Validation
Dishman Carbogen Amcis Ltd
China
Dishman Carbogen Amcis Ltd is a global CDMO and pharmaceutical outsourcing partner with operations across India, Switzerland, UK, France, Netherlands, and China. With 30 years of experience, they offer custom API development and manufacturing up to 100 metric ton scale, drug product capabilities including highly potent compounds and ADCs, plus finished dosage forms including soft gel capsules and encapsulation. They have received successful USFDA, PMDA, and EDQM inspections.
Frequently Asked Questions
How does PMDA GMP compare to FDA GMP?+
Both enforce cGMP standards, but PMDA places additional emphasis on: change control documentation (more detailed than FDA expectations), Japanese Pharmacopoeia compliance (JP, in addition to USP/EP), stability data under Japanese climate conditions (Zone II), and QA oversight of outsourced activities. CDMOs accustomed to FDA inspections may need to enhance their change control and documentation systems to meet PMDA expectations.
Is PMDA approval required for all drugs sold in Japan?+
Yes, all pharmaceutical products marketed in Japan must be manufactured at PMDA-inspected and approved facilities. This applies to both domestic Japanese manufacturers and foreign CDMOs producing for the Japanese market. PMDA conducts overseas facility inspections, though the frequency depends on product type and regulatory history.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
