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)
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Small Molecule Drug ProductOral Solid DoseFormulation Development
Vetter Pharma
Germany
Vetter Pharma is a leading global Contract Development and Manufacturing Organization specializing in aseptic fill-and-finish services for injectable drug products. Headquartered in Ravensburg, Germany, Vetter operates as an independent, family-owned business with over 75 years of experience.
Biologics Drug ProductFill/Finish (Vials)Fill/Finish (Syringes)
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.
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