Market
Pharmaceutical exports to Southeast Asia, ready to register
Progene Pharma supplies importers, distributors, hospital suppliers and tender suppliers across mainland and island Southeast Asia with generic medicines we manufacture in a WHO-GMP certified facility. Tested for hot, humid climates, labelled in English or the national language, and sent with the ASEAN dossier your authority asks for.
- Regions
- Mainland and island Southeast Asia
- Labels
- English and national languages
- Stability
- Zone IVb, 30 °C / 75% RH
- Dossiers
- ASEAN CTD and CTD
Why Southeast Asian distributors choose Progene Pharma
Progene Pharma makes the same molecules as the original brands, to the same pharmacopoeia standards, at a fraction of the price. Our facility is WHO-GMP certified, the standard most authorities in the region look for first, and also holds EU-GMP and ISO certification.
We ship by sea from Nhava Sheva (JNPT), near Mumbai, to Singapore, Port Klang, Jakarta, Ho Chi Minh City, Manila and other regional ports, and by air for urgent orders. We prepare the dossier and certificates your authority needs, and your company, as the local registrant, files them.
Medicines we supply to Southeast Asia
These are the products Southeast Asian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic medicines
Analgesics, antibiotics, antihistamines and gastric medicines in the strengths and packs pharmacies and clinics sell.
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Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and statins, as long-term conditions become a larger share of prescriptions across the region.
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Antimalarials and deworming
Artemisinin-based combinations, albendazole and mebendazole for the Greater Mekong countries and for school deworming programmes.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for government tenders and national health insurance suppliers.
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Vitamins and supplements
Multivitamins, vitamin C, vitamin D3, omega-3 and collagen products for a large and fast-growing supplements market.
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Herbal and traditional products
Herbal tablets, capsules and powders for markets where traditional medicine is widely used.
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Veterinary and personal care
Poultry and livestock medicines, and creams, washes and shampoos under your brand.
Medicine regulators in Southeast Asia
Each country registers medicines through its own regulator. These are the authorities in the largest markets; we prepare dossiers in the formats they expect.
- Philippines
- Food and Drug Administration (FDA Philippines)
- Vietnam
- Drug Administration of Vietnam (DAV)
- Indonesia
- National Agency of Drug and Food Control (BPOM)
- Thailand
- Food and Drug Administration (Thai FDA)
- Malaysia
- National Pharmaceutical Regulatory Agency (NPRA)
- Singapore
- Health Sciences Authority (HSA)
- Cambodia
- Department of Drugs and Food, Ministry of Health
- Myanmar
- Food and Drug Administration (Myanmar FDA)
- Laos
- Food and Drug Department, Ministry of Health
- Brunei
- Pharmaceutical Services, Ministry of Health
ASEAN countries share a common technical format, the ASEAN Common Technical Dossier (ACTD), and agree stability testing at 30 °C and 75% relative humidity, but each authority registers medicines for its own country and may add its own requirements. Most ask for a local licence holder. Rules differ by country, so check with your authority.
How registration usually works
Registration can take from several months to more than a year depending on the country, so many distributors register a few products first and add more as orders grow.
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01
Appoint a local registrant
A medicine is registered to a licensed company in the country, usually the importer or distributor, which holds the registration and deals with the authority.
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02
Submit the dossier
We prepare the ACTD or CTD dossier, the COPP, the GMP certificate and samples, and your team files them with the authority.
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03
Review and GMP check
The authority reviews the dossier, tests samples and, in some countries, asks for GMP clearance of the manufacturing site from its documents or after an inspection.
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04
Approval and import
Once approved, the registration number goes on the pack and each shipment is imported against the permits your country requires.
Made for Southeast Asian 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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Tested for heat and humidity
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition ASEAN authorities ask for, so the shelf life on the pack holds up in tropical conditions.
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Packaging that protects
Alu-alu or PVDC blisters and sealed bottles with desiccant for humid climates, and cartons strong enough for long sea and island journeys.
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Labels in your language
English or the national language of your market, such as Bahasa Indonesia, Vietnamese, Thai or Malay, with the registration number, batch details and patient leaflet your authority requires.
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Halal requirements
Halal rules apply to many products in Indonesia and Malaysia. Tell us early and we will confirm what we can supply, including vegetarian (HPMC) capsules.
Shipping to Southeast Asia
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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Singapore and Malaysia
Singapore, Port Klang and Penang, with onward road freight
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Indonesia and the Philippines
Jakarta (Tanjung Priok), Surabaya and Manila
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Vietnam, Thailand and Myanmar
Ho Chi Minh City, Hai Phong, Laem Chabang and Yangon
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin, COA and legalised documents where required
Questions about supplying Southeast Asia
Something else? Email [email protected].
Do you export medicines to Southeast Asia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, distributors, hospital suppliers and tender suppliers in the Philippines, Vietnam, Indonesia, Thailand, Malaysia and neighbouring countries.
Can you help us register products with BPOM, the Thai FDA or another ASEAN authority?
Yes. Progene Pharma prepares the documents registration needs: an ACTD or CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate and samples for testing. Your company, as the local registrant, files them with the authority, and we answer its questions with you.
What is the ASEAN Common Technical Dossier?
The ACTD is the shared registration format that ASEAN countries use for medicines, covering quality, manufacture and stability. Progene Pharma prepares the dossier in the format your authority accepts, and each authority may add its own requirements.
Do you supply packs labelled in Bahasa Indonesia, Vietnamese or Thai?
Yes. Progene Pharma prints cartons, labels and patient leaflets in English, Bahasa Indonesia, Vietnamese, Thai, Malay or another language, or in two languages on one pack, to match your registration.
Do you supply halal products for Indonesia and Malaysia?
Halal rules apply to many products in these markets. Tell us the product and the requirement and we will confirm what we can supply, including vegetarian (HPMC) capsules.
Are your medicines suitable for hot, humid climates?
Yes. Products for Southeast Asian markets 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 tropical conditions.
Do I need a local company to import medicines?
In most Southeast Asian countries, yes. A medicine is registered to a licensed local company, usually the importer or distributor, which then imports each shipment against the permits required. Rules differ by country, so check with your authority.
How are orders shipped to Southeast Asia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to ports such as Singapore, Port Klang, Jakarta, Ho Chi Minh City and Manila, or by air for urgent orders, on FOB, CFR or CIF terms.
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.
Explore more
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