Country · Southeast Asia
Pharmaceutical exports to Vietnam, ready for DAV registration
Progene Pharma supplies Vietnamese importers, distributors, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP and EU-GMP certified facility. We prepare the dossier, the COPP and the GMP evidence the Drug Administration of Vietnam asks for, label in Vietnamese, and ship to Ho Chi Minh City and Hai Phong.
- Regulator
- Drug Administration of Vietnam
- Labels
- Vietnamese required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Ho Chi Minh City, Hai Phong
The Vietnamese medicines market in brief
Vietnam is one of the fastest-growing pharmaceutical markets in Southeast Asia, with a large population, rising incomes and a health insurance system that now covers most people. It imports a large share of its medicines, and hospitals account for a major part of the market.
Antibiotics, pain medicines and gastric medicines are in steady demand, and diabetes, heart disease and high blood pressure are growing quickly. Vitamins and supplements sell in large volumes through pharmacy chains, which have expanded rapidly in Ho Chi Minh City and Hanoi.
Hospital tenders are central to the market. Vietnam groups the medicines in a tender by the manufacturing standard of the maker, with higher groups for products made to standards such as EU-GMP, so a manufacturer with EU-GMP certification can compete in the higher tender groups. Importers must be Vietnamese companies with the right licences.
Medicines we supply to Vietnam
These are the medicines Vietnamese 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 Ho Chi Minh City, Hanoi and Da Nang.
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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.
DAV registration, step by step
A medicine cannot be imported, sold or distributed in Vietnam until the Drug Administration of Vietnam (DAV), part of the Ministry of Health, has granted it a registration number. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
A company in Vietnam that holds the right licences, usually the importer, applies to the DAV on behalf of the manufacturer.
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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
DAV reviews it
The DAV assesses the dossier and may ask questions, which we answer with you.
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05
GMP evidence and samples
The DAV 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 DAV issues a registration with a registration number, which goes on every pack. It is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and DAV updates its requirements from time to time, so check the current guidelines with DAV or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Vietnam
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DAV application, through a licensed Vietnamese company
- The licences your business needs to import medicines
- The import licence or permit for each consignment, where required
- The customs declaration, through your customs broker
- Entry in hospital tenders, with the manufacturer's GMP evidence
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 DAV's questions during review
Made for Vietnamese 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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Labels in Vietnamese
Cartons and leaflets in Vietnamese, as Vietnamese rules require, with the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the DAV requires.
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EU-GMP for the tender groups
Our facility's EU-GMP certification supports bids in the higher groups of Vietnamese hospital tenders, which classify medicines by the manufacturer's GMP standard.
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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 climate.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities hospitals and pharmacy chains buy.
Shipping to Vietnam
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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Ho Chi Minh City
The main gateway, through the Cat Lai and Cai Mep terminals, for the south
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Hai Phong
The main northern port, with road freight to Hanoi
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Hanoi and Ho Chi Minh City
By air to Noi Bai or Tan Son Nhat airports for urgent orders and samples
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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 Vietnamese distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Hospital tenders
Public hospitals buy through tenders that group medicines by manufacturing standard, and ask for the full document set.
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Pharmacy chains
Fast-growing pharmacy chains in Ho Chi Minh City and Hanoi want branded packs of generics and supplements.
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Private hospitals and clinics
Private hospitals and clinics buy in hospital packs, often through distributors.
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Distributors
Licensed distributors supply pharmacies and hospitals across the north, centre and south.
Questions about supplying Vietnam
Something else? Email [email protected].
Do you export medicines to Vietnam?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Vietnam.
Can you help us register products with DAV?
Yes. Progene Pharma prepares the documents DAV 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 Vietnamese company submits the application, and we answer DAV's questions with you.
Do I need a local company to register and import?
Yes. The DAV registers a medicine through a company in Vietnam that holds the right licences, usually the importer. Check the current requirements with the DAV.
How long does DAV 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 DAV's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DAV ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DAV updates its requirements from time to time, so confirm the current list with DAV or your regulatory agent. We tell you what we can provide with your quotation.
Does EU-GMP certification matter in Vietnam?
Yes. Vietnamese hospital tenders group medicines by the manufacturing standard of the maker, and products made to a standard such as EU-GMP can compete in the higher groups. We send a copy of our certificates with the dossier. Check the current tender rules with your tender adviser.
Must the packs be in Vietnamese?
Yes. Vietnamese rules require the label and leaflet to carry Vietnamese text. We prepare the artwork to match your registration, and you approve a proof before printing.
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 Vietnam?
Vietnamese text, the DAV registration number, batch number, manufacture and expiry dates, storage conditions and the other details the DAV 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 conditions.
Can you supply tenders in Vietnam?
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 Vietnam?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Ho Chi Minh City or Hai Phong, or by air to Hanoi or Ho Chi Minh City 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