Regulatory-Ready Generics for ASEAN Importers
PIC/S GMP-certified generic medicines with full regulatory documentation support — ACTD, CPP, BE data, and stability studies available upon inquiry.
Documentation Available Upon Inquiry
Every product inquiry is supported by a full regulatory documentation package. The following document types are available for qualified products — provided upon contract signing as part of the project initiation process.
ACTD Dossier
AvailableASEAN Common Technical Document format — submission-ready for Thailand, Malaysia, Philippines, and Indonesia FDA registration.
CPP Certificate
AvailableCertificate of Pharmaceutical Product issued by Taiwan FDA, required for import license applications across all ASEAN markets.
Bioequivalence Data
AvailableBE study reports conducted under internationally accepted protocols — essential for hospital formulary inclusion and government tender qualification.
GMP Certificate
AvailablePIC/S GMP certification from Taiwan manufacturing facilities, the internationally harmonised standard accepted by ASEAN regulators.
Stability Studies
AvailableZone IVb long-term and accelerated stability data specific to tropical climate conditions across Southeast Asia.
CoA per Batch
AvailableCertificate of Analysis for every production batch, covering identity, potency, purity, and microbiological testing.
Therapeutic Areas
Our portfolio spans therapeutic areas covering the highest-demand generic pharmaceutical categories in Thailand and ASEAN hospital and outpatient markets. Specific product availability is confirmed upon inquiry.
Submit a Product Inquiry
Specify the generic name (INN), strength, dosage form, and target market — our regulatory affairs team will respond within 2 business days.
What to include
- →INN / Generic name
- →Strength(s) — e.g. 5mg, 10mg
- →Dosage form
- →Target market
- →Documents needed
- →Annual volume estimate
We respond to all pharmaceutical procurement inquiries within 2 business days.