Country · Southeast Asia
Pharmaceutical exports to the Philippines, ready for FDA registration
Progene Pharma supplies Philippine 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 Philippine Food and Drug Administration asks for, pack for tropical conditions, and ship to Manila.
- Regulator
- Food and Drug Administration
- Labels
- English, generic name prominent
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Manila
The Philippine medicines market in brief
The Philippines is one of the largest and fastest-growing pharmaceutical markets in Southeast Asia, with a population of well over a hundred million spread over thousands of islands. Generic medicines are central to government policy, and the country imports most of the medicines it uses.
Demand follows a heavy burden of infectious disease and a fast-growing burden of long-term conditions. Antibiotics, pain medicines and medicines for tuberculosis are in steady demand, diabetes and high blood pressure are among the leading causes of illness, and vitamins and supplements sell in very large volumes in pharmacies and drugstore chains.
Buyers include the Department of Health, public hospitals and local governments, which buy through government procurement, large drugstore chains and independent pharmacies, hospitals and distributors. Philippine law requires the generic name to appear prominently on the label, which shapes pack design.
Medicines we supply to Philippines
These are the medicines Philippine 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 Manila, Cebu and Davao.
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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.
FDA registration, step by step
A medicine cannot be imported, sold or distributed in the Philippines until the Food and Drug Administration (FDA) has granted a Certificate of Product Registration. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is applied for by an establishment in the Philippines that holds an FDA licence to operate, usually the importer or distributor, 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
FDA reviews it
The FDA assesses the dossier and may ask questions, which we answer with you.
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05
GMP evidence and samples
The FDA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples. Some generics also need bioequivalence data.
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06
Registration and renewal
On approval the FDA issues a Certificate of Product Registration, which carries the registration number that 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 FDA updates its requirements from time to time, so check the current guidelines with FDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Philippines
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The FDA application, as the licensed Philippine establishment
- The licence to operate as an importer or distributor
- Bioequivalence studies for generics, where the FDA asks for them
- The import clearance and customs declaration, through your customs broker
- Payment, and clearance at Manila
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 FDA's questions during review
Made for Philippine 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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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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The generic name on the label
English cartons and leaflets that show the generic name prominently, as Philippine law requires, with the registration number, batch number, manufacture and expiry dates and storage conditions.
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Packs for every channel
Pharmacy packs, hospital packs and government packs in the quantities drugstore chains, hospitals and local governments buy.
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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 Philippines
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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Manila
The main gateway, through the North and South Harbors and the international container terminal
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Cebu and Davao
The main ports for the Visayas and Mindanao
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Metro Manila
By air to Ninoy Aquino 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 clearance and customs declaration from your side
Where Philippine distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Drugstore chains and pharmacies
Large chains and independent pharmacies sell branded packs of the fast-moving generics and supplements.
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Hospitals
Private and public hospitals buy in hospital packs, often through group purchasing.
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Government procurement
The Department of Health and local governments buy through tenders and ask for the full document set.
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Distributors
Licensed distributors in Metro Manila and the regions supply pharmacies and hospitals across the islands.
Questions about supplying Philippines
Something else? Email [email protected].
Do you export medicines to Philippines?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Philippines.
Can you help us register products with FDA?
Yes. Progene Pharma prepares the documents FDA 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 Philippine company submits the application, and we answer FDA's questions with you.
Do I need a local company to register and import?
Yes. The FDA grants a registration to an establishment in the Philippines that holds a licence to operate, usually the importer or distributor. Check the current requirements with the FDA.
How long does FDA 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 FDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does FDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. FDA updates its requirements from time to time, so confirm the current list with FDA or your regulatory agent. We tell you what we can provide with your quotation.
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.
Why must the generic name be prominent?
Philippine law requires the generic name to appear prominently on the label, usually larger than the brand name. We design the artwork to follow this rule, and you approve a proof before printing.
Can you supply Department of Health and local government tenders?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Philippines?
English text with the generic name prominent, the FDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the FDA 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 Philippines?
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 Philippines?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Manila, or by air to Manila 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