How Companies in Thailand Can Source Pharma Products & CDMO Services (2026 Guide)

Thailand has one of the most developed pharmaceutical sectors in Southeast Asia. Universal health coverage, a large hospital network and an ageing population keep demand high for chronic-disease medicines, anti-infectives, oncology products and biologics. Local manufacturers produce many generics, but they depend on imported APIs, and much of the specialty and sterile range is imported as finished product.

Public hospitals account for a large share of purchasing, so tenders, essential-medicine listing and the Government Pharmaceutical Organization (GPO) all shape the market. This guide explains where supply typically comes from, how to qualify a manufacturer or CDMO, what Thai FDA expects, and how to handle common problems.

Thai buyers draw on several supply bases:

Thai FDA expects GMP at PIC/S level, since Thailand is a PIC/S member. Buyers therefore often favour sites with PIC/S-member or EU-GMP inspections, and keep a second qualified source for products that go into public tenders.

APIs for local manufacturing

Local formulators buy APIs such as paracetamol, ibuprofen, metformin, atorvastatin, pantoprazole, cefixime and ciprofloxacin.

Finished generics

• Tablets, capsules, oral liquids, sachets and topical products
• Anti-infective, cardiovascular, antidiabetic, gastrointestinal, respiratory and dermatology products

Specialty and hospital products

Oncology injectables, biologics and biosimilars, IV antibiotics, lyophilised products, small-volume parenterals and IV fluids for public and private hospitals.

Supplements and CDMO work

Thai brands contract vitamins, herbal products and private-label OTC lines, and use CDMOs for formulation development, technology transfer and contract packaging.

1. Define the requirement. Molecule, strength, dosage form, pack size, annual volume, API or finished product, and whether it needs a new Thai registration.
2. Check the channel. If you are targeting public hospitals, check whether the product is on the National List of Essential Medicines and how it is usually bought.
3. Shortlist and verify suppliers. Check GMP certificates (PIC/S-member inspections, EU-GMP or WHO-GMP) against official databases. Our supplier verification guide explains the checks.
4. Review the technical file. Ask for an ACTD dossier, Zone IVB stability data, CoA, COPP and, for APIs, a DMF or CEP. Generics usually need bioequivalence data.
5. Plan GMP clearance. Thai FDA assesses foreign sites, by document review or inspection, so prepare the supplier early.
6. Agree terms. MOQ, Thai artwork, lead time, Incoterms and payment terms.

PharmaTradz works with GMP-certified manufacturers and CDMOs across Asia, Europe, the Americas and Africa. Post your requirement on the RFQ page to compare qualified offers.

Main entry points

• Sea: Laem Chabang, the main deep-sea port, and Bangkok Port (Khlong Toei)
• Air: Suvarnabhumi Airport, the main pharma air-cargo gateway, and Don Mueang International Airport

Indicative transit

Air freight from Asian and European hubs typically takes 1–4 days. Sea freight from South or East Asia typically takes 1–3 weeks, and from Europe typically 4–6 weeks.

Cold chain and terms

Vaccines, biologics and many injectables need 2–8°C handling, validated packaging and data loggers. API buyers often use FOB or CIF, while finished-product buyers often prefer CIP or DAP. Our cold chain logistics service can help plan these shipments.

Customs

The Thai Customs Department clears goods, and drug imports go through Thai FDA checkpoints at ports and airports. Keep product names, registration numbers and batch data consistent across every document.

Thai FDA

Medicines are regulated by the Food and Drug Administration (Thai FDA) under the Ministry of Public Health, mainly under the Drug Act B.E. 2510 (1967).

Import licence and registration holder

Only a Thai-registered company with a drug import licence can import and register medicines. Foreign manufacturers therefore set up a Thai entity or appoint a licensed local partner as registration holder. The holder is responsible for pharmacovigilance, variations and renewals.

Dossier, GMP and stability

Thai FDA uses the ASEAN Common Technical Dossier (ACTD) as its main format, with electronic submission increasingly used. Foreign sites need GMP clearance, which may be granted on documents or after inspection. Stability data should cover Zone IVB conditions.

Labelling

Labels and package inserts must include Thai-language information. English may also appear.

Public procurement and GPO tenders

Public hospitals buy under the Public Procurement and Supplies Administration Act B.E. 2560 (2017), mostly through the government e-GP system. The National List of Essential Medicines guides what public hospitals use and reimburse. The Government Pharmaceutical Organization (GPO), a state enterprise under the Ministry of Public Health, makes and supplies medicines to the public sector and has long held a preferential position in public hospital buying. GPO also runs its own tenders for APIs and finished products. See our tender supply service for help.

Unregistered medicines

Thai FDA can allow limited import of unregistered medicines for specific needs, such as named patients or public-health programmes.

Thailand is a structured, quality-focused market. Success depends on a licensed local holder, a complete ACTD dossier, Zone IVB stability data, GMP clearance for the foreign site and a clear plan for public procurement. Use cost-competitive Asian supply for APIs and high-volume generics, and EU-GMP or US sources for specialty and biologic products.

PharmaTradz connects Thai buyers with GMP-certified manufacturers and CDMOs across Asia, Europe, the Americas and Africa. Visit our Thailand country hub for more market information.

Frequently Asked Questions

Can a foreign manufacturer register a medicine with Thai FDA directly?

No. Registration is held by a Thai-registered company with a drug import licence, either the manufacturer's own Thai entity or a licensed local partner.

Which dossier format does Thai FDA use?

The ASEAN Common Technical Dossier (ACTD) is the main format, with electronic submission increasingly used.

Must labels be in Thai?

Yes. Labels and package inserts must include Thai-language information; English can appear as well.

What is the GPO's role in Thai procurement?

The Government Pharmaceutical Organization is a state enterprise that makes and supplies medicines to public hospitals. It also runs its own tenders for APIs and finished products.

Does Thai FDA inspect foreign manufacturing sites?

Thai FDA requires GMP clearance for foreign sites. It may grant this on documents, such as PIC/S-member inspection reports, or after its own inspection.

Which stability zone applies to Thailand?

Zone IVB (30°C/75% RH), in line with ASEAN stability guidelines.