Country · Southeast Asia
Pharmaceutical exports to Myanmar, ready for FDA registration
Progene Pharma supplies Myanmar importers, distributors, hospital suppliers and NGOs with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Myanmar Food and Drug Administration asks for, pack for tropical conditions, and ship to Yangon.
- Regulator
- Food and Drug Administration
- Labels
- English, Myanmar where required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Yangon
The Myanmar medicines market in brief
Myanmar is a large Southeast Asian country that imports most of its medicines, many of them from its neighbours India, China and Thailand. Demand is high and unmet in many areas, but the market is also exposed to political, banking and logistics disruption, so conditions need to be confirmed before each order.
Malaria, tuberculosis and HIV are managed through national programmes with large donor funding, antibiotics, pain medicines and oral rehydration salts are in steady demand, and diabetes and high blood pressure are rising in Yangon and Mandalay. International organisations and NGOs are among the largest buyers and expect complete documentation.
Public supply runs through the Ministry of Health's central medical stores, while private importers, pharmacies and hospitals buy alongside it. Registration is held through a local company, and import licensing and payment channels can change quickly.
Medicines we supply to Myanmar
These are the medicines Myanmar 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 Yangon, Mandalay and Naypyidaw.
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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.
Myanmar FDA registration, step by step
A medicine cannot be imported, sold or distributed in Myanmar until the Food and Drug Administration (Myanmar 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 registered in Myanmar, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the Myanmar 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 CTD dossier 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
Myanmar FDA reviews it
The Myanmar FDA assesses the dossier and may ask questions, which we answer with you.
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05
Samples and inspection
The samples are tested, and the Myanmar FDA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the Myanmar FDA issues a registration and 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 Myanmar FDA updates its requirements from time to time, so check the current guidelines with Myanmar 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 Myanmar
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The Myanmar FDA application, as the registered local agent
- The licences your business needs to import and distribute medicines
- The import licence or permit for each consignment
- The customs declaration, through your clearing agent
- Payment arrangements, which need early planning
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 Myanmar FDA's questions during review
Made for Myanmar 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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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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Labels the Myanmar FDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the Myanmar FDA requires. We can add Myanmar text where your registration asks for it.
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Packs for every buyer
Pharmacy packs, hospital packs, programme packs and tender packs in the quantities distributors, hospitals and NGOs buy.
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Planning for disruption
Banking, import licensing and logistics in Myanmar can change quickly, so we confirm current conditions and agree payment and delivery terms clearly before an order.
Shipping to Myanmar
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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Yangon
Myanmar's main port, through the Yangon and Thilawa terminals, with road freight to Mandalay and Naypyidaw
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Yangon
By air to Yangon International Airport for urgent orders and samples
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Within Myanmar
Onward road freight to Mandalay 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 licence and customs declaration from your side
Where Myanmar distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Programmes and NGOs
International organisations buy malaria, tuberculosis, HIV and child health products in bulk and expect complete documentation.
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Public health supply
The central medical stores supply public hospitals and health centres, and buy through tenders.
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Pharmacies and private importers
Importers in Yangon and Mandalay supply pharmacies and clinics with branded packs of the fast-moving generics.
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Hospitals and clinics
Private hospitals and clinics buy in hospital packs, often through distributors.
Questions about supplying Myanmar
Something else? Email [email protected].
Do you export medicines to Myanmar?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Myanmar.
Can you help us register products with Myanmar FDA?
Yes. Progene Pharma prepares the documents Myanmar FDA registration needs: a CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Myanmar company submits the application, and we answer Myanmar FDA's questions with you.
Do I need a local company to register and import?
Yes. The Myanmar FDA registers a medicine through a company registered in Myanmar, usually the importer or distributor, which must also hold the licences to import and distribute medicines. Check the current requirements with the Myanmar FDA.
How long does Myanmar 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 Myanmar FDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does Myanmar 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. Myanmar FDA updates its requirements from time to time, so confirm the current list with Myanmar FDA or your regulatory agent. We tell you what we can provide with your quotation.
Is it safe to ship to Myanmar at the moment?
Banking, import licensing and logistics in Myanmar can change quickly. Before we quote, we confirm the current conditions, the payment route and the delivery terms with you, so an order goes ahead only on terms both sides can meet.
How is payment handled?
The banking channels available to Myanmar importers can change, so we agree the payment terms with you before an order and tell you which documents your bank needs.
Can you supply NGO and donor programmes?
Yes. We supply programme packs and the full document set that international organisations expect, including the COPP, GMP certificate and COA. Tell us the programme's requirements and we will confirm what we can provide.
What must the packs carry for Myanmar?
English text, the Myanmar FDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the Myanmar FDA requires, and Myanmar text where your registration asks for it. 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 Myanmar?
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 Myanmar?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Yangon, or by air to Yangon 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