Country · Southeast Asia
Pharmaceutical exports to Thailand, ready for Thai FDA registration
Progene Pharma supplies Thai importers, distributors, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the GMP evidence the Thai FDA asks for, label with Thai text, and ship to Laem Chabang and Bangkok.
- Regulator
- Thai FDA
- Labels
- Thai text required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Laem Chabang, Bangkok
The Thai medicines market in brief
Thailand is a middle-income market in Southeast Asia with a universal health coverage scheme, a strong network of public hospitals and a large private hospital sector that serves medical tourists. It has a local generics industry, and imports fill gaps in range and in hospital supply.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Public hospitals buy from a national list of essential medicines, so listing matters as much as registration.
The government's pharmaceutical organisation and joint purchasing arrangements supply public hospitals, while private hospital groups, pharmacy chains and distributors buy alongside them. Thailand is a member of the international GMP inspection scheme PIC/S, and its regulator expects complete, consistent dossiers.
Medicines we supply to Thailand
These are the medicines Thai distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Antimalarials
Artemether and lumefantrine tablets, dispersible tablets and dry syrup, and artesunate injection, for pharmacies, clinics and malaria programmes.
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Antibiotics
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in community pharmacies.
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HIV and tuberculosis
Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.
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Diabetes and blood pressure
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Bangkok, Chiang Mai and Khon Kaen.
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Deworming and child health
Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.
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Mother and child health
Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.
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Hospital supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.
Thai FDA registration, step by step
A medicine cannot be imported, sold or distributed in Thailand until the Food and Drug Administration (Thai FDA) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is held by a company in Thailand that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the Thai FDA.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the dossier in the ASEAN CTD format with Zone IVb stability data, the WHO-format COPP, the GMP certificate and the samples. We prepare all of these.
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04
Thai FDA reviews it
The Thai FDA assesses the dossier and may ask questions, which we answer with you. Some generics also need bioequivalence data.
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05
GMP evidence and samples
The Thai FDA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
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06
Registration and renewal
On approval the Thai FDA issues a registration with a registration number, which goes on every pack. The registration is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and Thai FDA updates its requirements from time to time, so check the current guidelines with Thai FDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Thailand
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The Thai FDA application, as the registered Thai company
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the Thai FDA asks for them
- The import permit and customs declaration, through your customs broker
- Listing for public hospital purchasing
Progene Pharma handles
- The CTD dossier, stability data and samples
- The COPP, the GMP certificate and the letter of authorisation
- A Certificate of Analysis for every batch
- Labels and leaflets with your registration number
- Invoice, packing list and certificate of origin
- Answers to Thai FDA's questions during review
Made for Thai conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Thai text on the label
Cartons and leaflets carry the information in Thai, as Thai rules require, with the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the Thai FDA requires.
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Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition ASEAN authorities ask for, with alu-alu or PVDC blisters and sealed bottles for the humid tropics.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities hospitals, chains and distributors buy.
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Documents that match the file
The COA, the COPP and the GMP certificate are prepared to match the dossier exactly, because inconsistencies slow review.
Shipping to Thailand
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Laem Chabang
Thailand's main container port, about two hours from Bangkok by road
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Bangkok
The river port in the capital, and Suvarnabhumi International Airport for urgent orders and samples
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Within Thailand
Onward road freight to Chiang Mai, Khon Kaen and the regions
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import permit and customs declaration from your side
Where Thai distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public hospitals
Government hospitals buy from the essential medicines list through the government pharmaceutical organisation and joint purchasing, and ask for the full document set.
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Private hospital groups
Large private hospital groups buy in hospital packs, often through group contracts.
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Pharmacies and chains
Pharmacy chains and independent pharmacies sell branded packs of everyday generics and supplements.
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Distributors
Licensed distributors in Bangkok and the regions supply pharmacies and hospitals across the country.
Questions about supplying Thailand
Something else? Email [email protected].
Do you export medicines to Thailand?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Thailand.
Can you help us register products with Thai FDA?
Yes. Progene Pharma prepares the documents Thai FDA registration needs: an ASEAN CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Thai company submits the application, and we answer Thai FDA's questions with you.
Do I need a local company to register and import?
Yes. The Thai FDA grants a registration to a company in Thailand that holds the right licences, usually the importer or distributor. Check the current requirements with the Thai FDA.
How long does Thai FDA registration take?
It varies by product and by how complete the dossier is, from several months to more than a year. A complete dossier with clear stability data and prompt answers to Thai FDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does Thai FDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. Thai FDA updates its requirements from time to time, so confirm the current list with Thai FDA or your regulatory agent. We tell you what we can provide with your quotation.
Must the packs carry Thai text?
Yes. Thai rules require the label and leaflet to carry the information in Thai. We prepare the artwork to match your registration, and you approve a proof before printing.
Does registration give access to public hospitals?
Not by itself. Public hospitals buy from a national list of essential medicines, so importers plan for listing as well as registration. Tell us your target and we will confirm which documents we can provide.
What is the ASEAN CTD?
It is the registration format that ASEAN countries share, covering quality, manufacture and stability. Progene Pharma prepares the dossier in the format your authority accepts, and each authority may add its own requirements.
What must the packs carry for Thailand?
Thai text, the Thai FDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the Thai FDA requires. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Products for this market are tested at 30 °C and 75% relative humidity (Zone IVb) and packed in moisture-resistant blisters or bottles, so the shelf life stays valid in hot, humid conditions.
Can you supply tenders in Thailand?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Thailand?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Laem Chabang or Bangkok, or by air to Bangkok for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
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Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494