Country · Southeast Asia
Pharmaceutical exports to Cambodia, ready for DDF registration
Progene Pharma supplies Cambodian 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 Department of Drugs and Food asks for, label to the department's requirements, and ship to Sihanoukville and Phnom Penh.
- Regulator
- Department of Drugs and Food
- Labels
- Khmer text required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Sihanoukville
The Cambodian medicines market in brief
Cambodia is a growing market in the Greater Mekong region, with a young population and rising incomes. It imports most of the medicines it uses, and a large informal sector means that quality-assured, correctly labelled products stand out.
Malaria is concentrated in remote 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 Phnom Penh and Siem Reap.
Public hospitals and health centres are supplied through the central medical store, while private pharmacies, clinics and hospitals buy through licensed importers. Cambodia is an ASEAN member and uses the ASEAN Common Technical Dossier (ACTD) format.
Medicines we supply to Cambodia
These are the medicines Cambodian 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 Phnom Penh, Siem Reap and Battambang.
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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.
DDF registration, step by step
A medicine cannot be imported or sold in Cambodia until the Department of Drugs and Food (DDF) 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 Cambodia that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the DDF.
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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
DDF reviews it
The DDF 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 DDF may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the DDF 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 DDF updates its requirements from time to time, so check the current guidelines with DDF or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Cambodia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DDF application, through a licensed Cambodian company
- The licences your business needs to import and distribute medicines
- The import permit for each consignment
- The customs declaration, through your clearing agent
- Payment, and clearance at the port
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 DDF's questions during review
Made for Cambodian 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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Khmer labels
Cartons and patient leaflets with Khmer text where the DDF 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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Packs that resist copying
Counterfeit and unregistered medicines circulate in the region, so we can add holograms, tamper-evident seals and codes to protect your brand and your patients.
Shipping to Cambodia
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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Sihanoukville
Cambodia's deep-water seaport, with road freight to Phnom Penh
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Phnom Penh
The river port and the road hub for the rest of the country
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Phnom Penh and Siem Reap
By air 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 Cambodian 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 Phnom Penh 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 Cambodia
Something else? Email [email protected].
Do you export medicines to Cambodia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Cambodia.
Can you help us register products with DDF?
Yes. Progene Pharma prepares the documents DDF 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 Cambodian company submits the application, and we answer DDF's questions with you.
Do I need a local company to register and import?
Yes. The DDF registers a medicine through a pharmaceutical company in Cambodia that holds the right licences, usually the importer or distributor. Check the current requirements with the DDF.
How long does DDF 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 DDF's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DDF ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DDF updates its requirements from time to time, so confirm the current list with DDF 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 DDF accepts, and the DDF may add its own requirements.
Do the packs need Khmer text?
Cambodia asks for Khmer text on labels and leaflets, as set out by the DDF. We prepare the artwork to match your registration, and you approve a proof before printing.
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 Cambodia?
Khmer text where the DDF requires it, the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the DDF 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 Cambodia?
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 Cambodia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Sihanoukville, or by air to Phnom Penh 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.
Related pages
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