Country · Southeast Asia
Pharmaceutical exports to Indonesia, ready for BPOM registration
Progene Pharma supplies Indonesian 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 BPOM asks for, label in Bahasa Indonesia, tell you what halal requires, and ship to Jakarta and Surabaya.
- Regulator
- BPOM
- Labels
- Bahasa Indonesia required
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Jakarta, Surabaya
The Indonesian medicines market in brief
Indonesia is the largest pharmaceutical market in Southeast Asia and the fourth most populous country in the world, spread over thousands of islands. A national health insurance scheme now covers most of the population, which has made generic medicines a very large and fast-growing market.
Antibiotics, pain medicines, gastric products and vitamins sell in large volumes, and diabetes, heart disease and high blood pressure are rising quickly. Government policy favours local manufacturing, so a large share of the market is supplied by Indonesian producers, and foreign products work best where a local partner is involved and the product fills a gap.
Public purchasing for the national insurance scheme runs largely through an electronic catalogue, while hospitals, pharmacy chains and distributors buy alongside it. Halal certification is becoming a requirement for medicines under Indonesian law, which makes early planning important.
Medicines we supply to Indonesia
These are the medicines Indonesian 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 Jakarta, Surabaya and Bandung.
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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.
BPOM registration, step by step
A medicine cannot be imported, sold or distributed in Indonesia until the National Agency of Drug and Food Control (BPOM) has granted a marketing authorisation. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The authorisation is applied for by a licensed pharmaceutical company in Indonesia, usually the importer or a local partner, acting for 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
BPOM reviews it
BPOM 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
BPOM 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 BPOM issues a marketing authorisation with a registration number, which goes on every pack. The authorisation is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and BPOM updates its requirements from time to time, so check the current guidelines with BPOM or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Indonesia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The BPOM application, through a licensed Indonesian pharmaceutical company
- The licences your business needs to import and distribute medicines
- Halal certification, where it applies to your product
- The import permit and customs declaration, through your customs broker
- Entry in the electronic catalogue, for public 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 BPOM's questions during review
Made for Indonesian 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 Bahasa Indonesia
Cartons and patient leaflets in Bahasa Indonesia, as Indonesian rules require, with the registration number, batch number, manufacture and expiry dates, storage conditions and the other details BPOM requires.
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Halal planning
Halal certification is becoming a requirement for medicines under Indonesian law. Tell us early, and we confirm what we can supply, including vegetarian (HPMC) capsules.
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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 island logistics
Strong outer cartons and palletised loads for transport between islands, where handling is rough and loads sit in heat.
Shipping to Indonesia
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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Jakarta
The main gateway, through the Tanjung Priok port, with road freight across Java
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Surabaya
The second port, for East Java and the eastern islands
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Jakarta
By air to Soekarno-Hatta 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 Indonesian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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National health insurance supply
Public purchasing for the national scheme runs largely through an electronic catalogue, and asks for the full document set.
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Pharmacy chains
Large pharmacy chains and independent pharmacies want branded packs of everyday generics and supplements.
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Hospitals
Private and public hospitals buy in hospital packs, often through distributors.
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Distributors
Licensed distributors in Jakarta and the regions supply pharmacies and hospitals across the islands.
Questions about supplying Indonesia
Something else? Email [email protected].
Do you export medicines to Indonesia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Indonesia.
Can you help us register products with BPOM?
Yes. Progene Pharma prepares the documents BPOM 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 Indonesian company submits the application, and we answer BPOM's questions with you.
Do I need a local company to register and import?
Yes. BPOM grants a marketing authorisation to a licensed pharmaceutical company in Indonesia, usually the importer or a local partner. Check the current requirements with BPOM.
How long does BPOM 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 BPOM's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does BPOM ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. BPOM updates its requirements from time to time, so confirm the current list with BPOM or your regulatory agent. We tell you what we can provide with your quotation.
Do medicines need halal certification in Indonesia?
Indonesian law is making halal certification a requirement for medicines, in stages. Tell us the product and we will confirm what we can supply and what documents are available. Check the current timetable with the authorities.
Does Indonesia favour local manufacturers?
Yes. Government policy encourages local manufacturing and local content, so imports work best where a local partner is involved and the product fills a gap. Tell us your plan and we will say how we can help.
Can you supply public purchasing through the electronic catalogue?
Public purchasing for the national scheme runs largely through an electronic catalogue, where products must be listed. Progene Pharma supplies the product documents your company needs for listing. Tell us the requirements and we will confirm what we can provide.
What must the packs carry for Indonesia?
Bahasa Indonesia text, the BPOM registration number, batch number, manufacture and expiry dates, storage conditions and the other details BPOM 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 Indonesia?
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 Indonesia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Jakarta or Surabaya, or by air to Jakarta 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