Country · Southeast Asia
Pharmaceutical exports to Laos, ready for FDD registration
Progene Pharma supplies Lao importers, wholesalers, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Food and Drug Department asks for, label to the department's requirements, and ship through Thai and Vietnamese ports for the road inland.
- Regulator
- Food and Drug Department
- Labels
- Lao text required
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Laem Chabang, Da Nang
The Lao medicines market in brief
Laos is a small, landlocked country in the Greater Mekong region. Its medicines arrive by sea through Thai or Vietnamese ports and then travel inland by road, so lead times and transit paperwork matter. It imports most of the medicines it uses.
Malaria remains a concern in forested provinces and is supported by regional elimination programmes, while antibiotics, pain medicines, gastric products, vitamins and, increasingly, diabetes and high blood pressure medicines drive demand in Vientiane and Savannakhet.
Public hospitals and health centres are supplied through the central medical store and programme purchasing, while private pharmacies and clinics buy through licensed importers. Laos is an ASEAN member and uses the ASEAN Common Technical Dossier (ACTD) format.
Medicines we supply to Laos
These are the medicines Lao 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 Vientiane, Savannakhet and Pakse.
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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.
FDD registration, step by step
A medicine cannot be imported or sold in Laos until the Food and Drug Department (FDD) of the Ministry of Health 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 pharmaceutical company in Laos that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the FDD.
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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 ACTD 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
FDD reviews it
The FDD 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 FDD may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the FDD 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 FDD updates its requirements from time to time, so check the current guidelines with FDD or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Laos
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The FDD application, through a licensed Lao company
- The licences your business needs to import and distribute medicines
- The import permit for each consignment
- The customs declaration, through your clearing agent
- Transit through the port and the road journey inland
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 FDD's questions during review
Made for Lao 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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Lao labels
Cartons and patient leaflets with Lao text where the FDD requires it, together with the registration number, batch number, expiry date and storage conditions, and an approved proof before printing.
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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 conditions.
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Packs for every channel
Pharmacy packs, hospital packs, programme packs and tender packs in the quantities importers, hospitals and the central medical store buy.
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Cartons for the road
Strong outer cartons and palletised loads for the road journey from the coast, where loads sit in heat and handling is rough.
Shipping to Laos
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
The Thai deep-water port, with road freight through Thailand to Vientiane across the Friendship Bridge
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Da Nang
The Vietnamese port, an alternative route by road to southern and central Laos
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Vientiane
By air to Wattay International Airport 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, transit documents and customs declaration from your side
Where Lao distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The central medical store supplies public hospitals and health centres and asks for the full document set.
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Programmes and NGOs
Programmes and international organisations buy malaria and child health products in bulk and expect complete documentation.
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Pharmacies
Pharmacies in Vientiane and the provinces sell branded packs of the fast-moving generics.
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Private hospitals and clinics
Private hospitals and clinics buy in hospital packs through licensed importers.
Questions about supplying Laos
Something else? Email [email protected].
Do you export medicines to Laos?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Laos.
Can you help us register products with FDD?
Yes. Progene Pharma prepares the documents FDD 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 Lao company submits the application, and we answer FDD's questions with you.
Do I need a local company to register and import?
Yes. The FDD registers a medicine through a pharmaceutical company in Laos that holds the right licences, usually the importer or distributor. Check the current requirements with the FDD.
How long does FDD 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 FDD's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does FDD ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. FDD updates its requirements from time to time, so confirm the current list with FDD or your regulatory agent. We tell you what we can provide with your quotation.
What is the ACTD?
The ASEAN Common Technical Dossier is the shared registration format that ASEAN countries use for medicines, covering quality, manufacture and stability. Progene Pharma prepares the dossier in the format the FDD accepts, and the FDD may add its own requirements.
How do medicines reach Laos?
Laos is landlocked, so shipments go by sea to a Thai or Vietnamese port and then by road, under a transit procedure. Your clearing agent handles transit and customs, and we confirm the schedule with your quotation.
Can you supply programmes and NGOs?
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 Laos?
Lao text where the FDD requires it, the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the FDD 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 Laos?
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 Laos?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Laem Chabang in Thailand or Da Nang in Vietnam, with onward road freight to Vientiane, or by air to Vientiane 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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- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494