Country · Southeast Asia
Pharmaceutical exports to Malaysia, ready for NPRA registration
Progene Pharma supplies Malaysian importers, distributors, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the GMP evidence the National Pharmaceutical Regulatory Agency asks for, label in English and Malay, and ship to Port Klang.
- Regulator
- NPRA and the Drug Control Authority
- Labels
- English and Malay
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Port Klang, Penang
The Malaysian medicines market in brief
Malaysia is a well-regulated middle-income market with a strong generics industry, public and private hospitals and a growing pharmacy sector. It is a member of the international GMP inspection scheme PIC/S, and its regulator expects complete, consistent dossiers and proof of GMP compliance.
Antibiotics, pain medicines, gastric products and supplements sell in large volumes, and diabetes, heart disease and high blood pressure are among the most common long-term conditions. Medicines for hospitals and clinics are bought through government procurement and by large private hospital groups.
Public hospitals buy products that appear on the Ministry of Health's approved purchase list, so registration alone is not enough, and importers plan for listing as well. Pharmacy chains, distributors and private hospitals buy alongside the public system.
Medicines we supply to Malaysia
These are the medicines Malaysian 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 Kuala Lumpur, Penang and Johor Bahru.
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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.
NPRA registration, step by step
A medicine cannot be imported, sold or distributed in Malaysia until the Drug Control Authority, supported by the National Pharmaceutical Regulatory Agency (NPRA), 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 in Malaysia that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the NPRA.
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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
NPRA reviews it
The NPRA assesses the dossier and may ask questions, which we answer with you. Some generics also need bioequivalence data.
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05
GMP evidence and samples
The NPRA 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 Drug Control Authority issues a registration with 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 NPRA updates its requirements from time to time, so check the current guidelines with NPRA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Malaysia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The NPRA application, as the registered Malaysian company
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the NPRA asks for them
- The import permit and customs declaration, through your customs agent
- Listing for public hospital purchasing
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 NPRA's questions during review
Made for Malaysian 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 English and Malay
Cartons and patient leaflets in English and Malay, with the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the NPRA requires, 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 tropics.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities hospitals, chains and distributors buy.
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Halal requirements
Halal certification is common for products sold to Muslim consumers. Tell us early and we will confirm what we can supply, including vegetarian (HPMC) capsules.
Shipping to Malaysia
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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Port Klang
Malaysia's main port, with road freight to Kuala Lumpur and the rest of the peninsula
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Penang
The northern port, for the north of the peninsula
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Kuala Lumpur
By air to Kuala Lumpur 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 and customs declaration from your side
Where Malaysian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public hospitals
Government hospitals buy products on the Ministry of Health's approved purchase list through tenders, and ask for the full document set.
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Private hospital groups
Private hospital groups buy in hospital packs, often through group contracts.
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Pharmacies and chains
Pharmacy chains and independent pharmacies want branded packs of everyday generics and supplements.
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Distributors
Licensed distributors in the Klang Valley and Penang supply pharmacies and clinics across the country.
Questions about supplying Malaysia
Something else? Email [email protected].
Do you export medicines to Malaysia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Malaysia.
Can you help us register products with NPRA?
Yes. Progene Pharma prepares the documents NPRA 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 Malaysian company submits the application, and we answer NPRA's questions with you.
Do I need a local company to register and import?
Yes. The Drug Control Authority registers a medicine to a company in Malaysia that holds the right licences, usually the importer or distributor. Check the current requirements with the NPRA.
How long does NPRA 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 NPRA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does NPRA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. NPRA updates its requirements from time to time, so confirm the current list with NPRA or your regulatory agent. We tell you what we can provide with your quotation.
Does registration give access to government hospitals?
Not by itself. Public hospitals buy products on the Ministry of Health's approved purchase list, so importers plan for listing as well as registration. Tell us your target and we will confirm which documents we can provide.
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.
Do you supply halal-suitable products?
Halal certification is common in Malaysia. Tell us the product and the requirement and we will confirm what we can supply, including vegetarian (HPMC) capsules.
What must the packs carry for Malaysia?
English and Malay text, the NPRA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the NPRA 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 Malaysia?
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 Malaysia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Port Klang or Penang, or by air to Kuala Lumpur 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