Country · Africa
Pharmaceutical exports to South Africa, ready for SAHPRA registration
Progene Pharma supplies South African 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 GMP evidence the South African Health Products Regulatory Authority asks for, and ship to Durban and Cape Town.
- Regulator
- SAHPRA
- Labels
- English, with the registration number
- Dossier
- CTD, South African format
- Main ports
- Durban, Cape Town
The South African medicines market in brief
South Africa has the largest and most developed pharmaceutical market in Africa, with a strong local generics industry, large wholesalers and national pharmacy chains. It is also the most regulated, so registration here is more demanding and slower than in most African countries, and importers plan for it early.
Demand covers the whole range of generics. HIV and tuberculosis treatment is delivered at very large scale through national programmes, diabetes and high blood pressure are among the most common long-term conditions, and antibiotics, pain medicines and chronic care are the staples of both public and private supply. Private-sector prices are regulated through the single exit price.
Buyers include the national and provincial departments of health, which buy through national tenders, private hospital groups, pharmacy chains and wholesalers. A foreign manufacturer works through a South African company that holds the registration and the licences to import and distribute.
Medicines we supply to South Africa
These are the medicines South African 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 Johannesburg, Cape Town, Durban and Pretoria.
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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.
SAHPRA registration, step by step
A medicine cannot be sold in South Africa until the South African Health Products Regulatory Authority (SAHPRA) 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 registered in South Africa, the applicant, which must also hold the licences to import and distribute medicines. It applies to SAHPRA.
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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 CTD format with the South African regional information, stability data for the required climate zone, the WHO-format COPP, the GMP certificate and the samples. We prepare the manufacturer's part of all of these.
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04
SAHPRA reviews it
SAHPRA assesses the dossier and may ask questions, which we answer with you. Review takes longer here than in most African countries.
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05
GMP evidence and samples
SAHPRA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may ask for samples to be tested.
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06
Registration and renewal
On approval SAHPRA issues a registration and a registration number, which goes on every pack. The registration is kept in force by meeting SAHPRA's continuing requirements.
Registration takes from several months to more than a year, and SAHPRA updates its requirements from time to time, so check the current guidelines with SAHPRA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into South Africa
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The SAHPRA application, as the registered South African applicant
- The licences your business needs to import and distribute medicines
- The import permits and declarations for each consignment
- Customs clearance with the South African Revenue Service, through your clearing agent
- Pricing under the single exit price rules
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 SAHPRA's questions during review
Made for South African 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 the South African format
English cartons and patient information leaflets laid out to SAHPRA's requirements, with the registration number, batch number, expiry date and storage conditions.
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Stability for the zone you need
Stability studies at the climate zone SAHPRA requires, with moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the national and provincial tenders, wholesalers and chains buy.
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Documents that match the file
The COA, the COPP and the GMP certificate are prepared to match the dossier exactly, because inconsistencies slow South African review.
Shipping to South Africa
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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Durban
South Africa's busiest container port, with road and rail freight to Johannesburg and Pretoria
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Cape Town
The second major port, for the Western Cape and the south
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Johannesburg
By air to O. R. Tambo 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 permits and customs declaration from your side
Where South African distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The national and provincial departments of health buy through national tenders, and ask for the full document set.
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Private hospital groups
Large private hospital groups buy in hospital packs, often through group contracts.
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Pharmacies and chains
National pharmacy chains and independent pharmacies sell generics under the single exit price, and want consistent quality and supply.
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Wholesalers and distributors
Licensed wholesalers in Gauteng, KwaZulu-Natal and the Western Cape supply pharmacies and dispensing doctors.
Questions about supplying South Africa
Something else? Email [email protected].
Do you export medicines to South Africa?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in South Africa.
Can you help us register products with SAHPRA?
Yes. Progene Pharma prepares the documents SAHPRA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your South African company submits the application, and we answer SAHPRA's questions with you.
Do I need a local company to register and import?
Yes. SAHPRA registers a medicine to a company established in South Africa, which must also hold the licences to import and distribute medicines. Check the current requirements with SAHPRA.
How long does SAHPRA 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 SAHPRA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does SAHPRA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. SAHPRA updates its requirements from time to time, so confirm the current list with SAHPRA or your regulatory agent. We tell you what we can provide with your quotation.
Is registration slower in South Africa?
Often, yes. SAHPRA is a demanding regulator and review can take longer than in most African countries, so importers plan for it early. A complete, consistent dossier and prompt answers to SAHPRA's questions help.
What is the single exit price?
It is the regulated price at which manufacturers and importers sell medicines in the South African private sector, set by the government. It affects what price your distributor can charge, so agree your margins with it in mind.
Can you supply national and provincial 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 South Africa?
English text, the SAHPRA registration number, batch number, manufacture and expiry dates, storage conditions and the other details SAHPRA requires, with the patient information leaflet in the South African format. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Progene Pharma tests products at the climate zone your authority requires and packs them in moisture-resistant blisters or bottles, so the shelf life stays valid.
Can you supply tenders in South Africa?
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 South Africa?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Durban or Cape Town, or by air to Johannesburg 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.
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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