Quality
Filed, inspected, and verifiable.
Trust on a pharmaceutical supply chain is built on paperwork. Here is ours: the certifications, sites and filings behind the catalog.
Regulatory authorities
- NMPA (China)
- EMA (EU)
- US FDA (United States)
- COFEPRIS (Mexico)
- INVIMA (Colombia)
- ANVISA (Brazil)
- PMDA (Japan)
- MFDS (South Korea)
- TGA (Australia)
Certificates
GMPFDA EIRCEPKorea MFDSAustralia TGA
These certifications describe our manufacturing and quality footprint. Product-specific regulatory status is stated only on each product page, exactly as filed.
International API production base
Type
cGMP manufacturing facility
Workshops
15 workshops; 8 clean rooms
Qualifications
US FDA, EU GMP, Korea MFDS, Chinese GMP
Employees
350
Category
API, INT. I, CDMO & CMO
Sustainability
Registered with EcoVadis
Semaglutide capacity
10 MT/year
Tirzepatide capacity
3 MT/year
Proximity
≈2 hours to both Shanghai and Beijing
Regulatory status across the catalog
Filings behind 90 products
Every product page states its regulatory status exactly as filed, no more and no less. Across the catalog, the filings break down as follows.
DMF44
GMP35
Local GMP17
NMPA approval14
VMF6
NDC6
COFPRIS5
US DMF5
5 international GMPs2
FDA2
WC1
EU GMP1
DMF on-going1
CEP1