Country · Southeast Asia
Pharmaceutical exports to Singapore, ready for HSA registration
Progene Pharma supplies Singapore importers, wholesalers and regional distributors with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the GMP evidence the Health Sciences Authority asks for, label in English, and ship to the Port of Singapore.
- Regulator
- Health Sciences Authority
- Labels
- English
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Singapore
The Singaporean medicines market in brief
Singapore is a small, high-income market with a strict and well-respected regulator. It imports almost all of its medicines, and it is also a regional hub, so many distributors hold stock there for sale across Southeast Asia.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Public hospitals and polyclinics buy through group purchasing, and a large private sector of clinics, hospitals and pharmacies buys through licensed importers.
The Health Sciences Authority assesses a medicine for quality, safety and efficacy before it can be sold, and may ask for more evidence of GMP compliance and bioequivalence than most markets in the region. It suits manufacturers that can supply a thorough dossier.
Medicines we supply to Singapore
These are the medicines Singaporean distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
-
Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
-
Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
-
Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
-
Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Singapore.
-
Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
-
Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
-
Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
-
Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
HSA registration, step by step
A medicine cannot be sold in Singapore until the Health Sciences Authority (HSA) has registered it, and a licensed company must import and distribute it. This is the usual route for a finished pharmaceutical product made abroad.
-
01
A local company applies
The product is registered through a company established in Singapore, usually the importer or distributor, acting for the manufacturer. It applies to the HSA.
-
02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
-
03
The dossier goes in
The applicant submits the dossier with stability data, the WHO-format COPP, the GMP evidence and the samples, with the route (full or abridged evaluation) chosen to suit the product. We prepare the manufacturer's documents.
-
04
HSA reviews it
The HSA assesses the dossier and may ask questions, which we answer with you. A generic may need bioequivalence data.
-
05
GMP evidence and samples
The HSA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
-
06
Registration and renewal
On approval the HSA issues a product licence, and the product can be sold under the importer's wholesale licence. The licence is maintained and renewed according to the HSA's conditions.
Registration takes from several months to more than a year, and HSA updates its requirements from time to time, so check the current guidelines with HSA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Singapore
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The HSA application, as the registered local holder
- The wholesale dealer's licence your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the HSA asks for them
- The import permit and customs declaration, through your 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 product licence number
- Invoice, packing list and certificate of origin
- Answers to HSA's questions during review
Made for Singaporean conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
-
English labels
Cartons and patient leaflets in English, with the product licence number, batch number, expiry date and storage conditions the HSA requires, and an approved proof before printing.
-
A thorough dossier
A complete, well-organised file with the stability data and the GMP evidence the HSA expects, because gaps slow review.
-
Packs for every channel
Pharmacy packs, clinic packs and hospital packs in the quantities private importers and group purchasers buy.
-
Regional stock
Packs and documents consistent across markets, for distributors who hold stock in Singapore for sale elsewhere in Southeast Asia.
Shipping to Singapore
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Port of Singapore
One of the world's busiest ports, with short transit from Nhava Sheva
-
Changi Airport
Fast air freight for urgent orders and samples
-
Onward to the region
Regional distributors forward goods by sea or road to Malaysia, Indonesia and beyond
-
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 Singaporean distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Public hospitals and polyclinics
Public institutions buy through group purchasing and ask for the full document set.
-
Private hospitals and clinics
Private hospitals and clinic groups buy in hospital packs through licensed importers.
-
Pharmacies and chains
Pharmacy chains and independent pharmacies sell branded packs of everyday generics and supplements.
-
Regional distributors
Distributors hold stock in Singapore for sale across Southeast Asia and need consistent labelling and documents.
Questions about supplying Singapore
Something else? Email [email protected].
Do you export medicines to Singapore?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Singapore.
Can you help us register products with HSA?
Yes. Progene Pharma prepares the documents HSA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Singaporean company submits the application, and we answer HSA's questions with you.
Do I need a local company to register and import?
Yes. The HSA registers a medicine through a company established in Singapore, which must hold the right wholesale licence. Check the current requirements with the HSA.
How long does HSA 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 HSA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does HSA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. HSA updates its requirements from time to time, so confirm the current list with HSA or your regulatory agent. We tell you what we can provide with your quotation.
Is Singapore a good first market for a generic?
It is a demanding one, because the HSA asks for a thorough dossier, but a Singapore registration builds credibility and the market is also a hub for regional distribution. Many importers add it after registering in simpler markets. Tell us the product and we will say how it fits.
Do generics need bioequivalence studies in Singapore?
Often, yes, depending on the product and the evaluation route. Tell us the product and we will confirm what is needed before you apply.
Can you supply regional distributors based in Singapore?
Yes. We supply packs and documents for distributors who hold stock in Singapore for sale elsewhere in the region, with consistent labelling across markets. Tell us the countries and we will confirm what we can provide.
What must the packs carry for Singapore?
English text, the HSA product licence number, batch number, manufacture and expiry dates, storage conditions and the other details HSA 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 Singapore?
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 Singapore?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Singapore, or by air to Singapore 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