Progene Pharma

Markets

Pharmaceutical exports from India to five regions

Progene Pharma supplies distributors, importers and tender suppliers in Africa, the Middle East, Southeast Asia, Latin America, North America and Europe. We manufacture in a WHO-GMP certified facility in India and send each shipment with the certificates, the dossier and the labels your regulator expects.

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Shipping
Sea and air
Manufacturing
WHO-GMP certified
Documents
COA, COPP, CTD dossier
Labels
In your language

Where we supply

Every country registers medicines through its own regulator and has its own import rules. Pick your region for the authorities, the paperwork and what to expect.

Africa

Our largest market. Progene Pharma supplies distributors, importers and tender suppliers across West, East, Southern, Central and North Africa with generic medicines tested for hot, humid climates, including antimalarials, antibiotics, analgesics and vitamins.

Nigeria
NAFDAC
Kenya
Pharmacy and Poisons Board
Ghana
Food and Drugs Authority
Tanzania
TMDA
Show 12 more countries
Uganda
National Drug Authority
Ethiopia
Ethiopian Food and Drug Authority
South Africa
SAHPRA
Zambia
ZAMRA
Zimbabwe
MCAZ
Rwanda
Rwanda FDA
Malawi
Pharmacy and Medicines Regulatory Authority
Mozambique
ANARME
Côte d'Ivoire
AIRP
Senegal
Agence de Réglementation Pharmaceutique
DR Congo
ACOREP
Egypt
Egyptian Drug Authority
Labels
English, French, Portuguese, Arabic
Stability
Zone IVb, 30 °C / 75% RH

Read the Africa guide

Middle East

Progene Pharma supplies pharmacies, distributors and hospital suppliers in the Gulf and the Levant. Registration runs through each country's ministry or drug authority and usually asks for a COPP, a GMP certificate and Arabic or bilingual labelling.

Saudi Arabia
Saudi Food and Drug Authority (SFDA)
United Arab Emirates
Emirates Drug Establishment and the Ministry of Health and Prevention
Jordan
Jordan Food and Drug Administration (JFDA)
Iraq
Ministry of Health
Show 6 more countries
Kuwait
Ministry of Health
Oman
Ministry of Health
Qatar
Ministry of Public Health
Bahrain
National Health Regulatory Authority (NHRA)
Lebanon
Ministry of Public Health
Yemen
Supreme Board of Drugs and Medical Appliances
Labels
Arabic and English, on one pack if needed
Stability
Hot-climate data, as the regulator asks

Read the Middle East guide

Southeast Asia

Progene Pharma supplies importers and distributors in the Philippines, Vietnam, Indonesia and neighbouring countries. These markets follow the ASEAN common technical dossier and test stability for hot, humid conditions, and several ask for labels in the national language.

Philippines
Food and Drug Administration
Vietnam
Drug Administration of Vietnam (DAV)
Indonesia
BPOM
Thailand
Thai FDA
Show 6 more countries
Malaysia
National Pharmaceutical Regulatory Agency (NPRA)
Singapore
Health Sciences Authority (HSA)
Cambodia
Department of Drug and Food
Myanmar
Food and Drug Administration
Laos
Food and Drug Department
Brunei
Pharmaceutical Services, Ministry of Health
Labels
English and the national language
Stability
Zone IVb, 30 °C / 75% RH

Read the Southeast Asia guide

Latin America

Progene Pharma supplies registered distributors in Mexico, Colombia, Brazil and the rest of the region. Registration is strict and local: the national regulator inspects or reviews the manufacturing site, and packs carry Spanish or Portuguese text.

Mexico
COFEPRIS
Colombia
INVIMA
Brazil
ANVISA
Argentina
ANMAT
Show 8 more countries
Chile
Instituto de Salud Pública (ISP)
Peru
DIGEMID
Ecuador
ARCSA
Bolivia
AGEMED
Paraguay
DINAVISA
Panama
Dirección Nacional de Farmacia y Drogas
Dominican Republic
Dirección General de Drogas y Farmacias
Uruguay
Ministry of Public Health
Labels
Spanish or Portuguese
Stability
As the regulator asks, by climate zone

Read the Latin America guide

North America

Progene Pharma supplies importers, brand owners and distributors in the United States and Canada. Rules depend on the product: supplements, cosmetics, over-the-counter medicines and prescription generics each follow their own route, and the importer holds the listings, licences and approvals. We prepare the manufacturer's documents and confirm what a product needs before we quote.

United States
Food and Drug Administration (FDA)
Canada
Health Canada
Labels
English; English and French for Canada
Stability
Climate Zone II, 25 °C / 60% RH

Read the North America guide

Europe

Progene Pharma supplies importers and distributors in Europe. Within the EU a medicine needs a marketing authorisation held by a company in the EU, so we work with your company as the holder and provide the dossier and the manufacturing certificates it needs, including our EU-GMP certification.

European Union
European Medicines Agency and national agencies
Germany
BfArM
United Kingdom
MHRA
Spain
AEMPS
Show 9 more countries
France
ANSM
Italy
AIFA
Netherlands
Medicines Evaluation Board
Poland
URPL
Romania
ANMDMR
Portugal
INFARMED
Ireland
HPRA
Türkiye
Turkish Medicines and Medical Devices Agency (TİTCK)
Greece
EOF
Labels
The language of each country
Quality
WHO-GMP, EU-GMP and ISO certified

Read the Europe guide

What comes with every export order

Whatever the destination, Progene Pharma prepares the same core file, then adds what your regulator asks for on top.

  • Certificate of Analysis

    A COA for each batch, so your customs and quality teams can check what was made against the specification.

  • Certificate of Pharmaceutical Product

    A WHO-format COPP and the GMP certificates of the facility, which most regulators ask for before they accept a registration.

  • Registration dossier

    A CTD dossier for the product, with stability data for the climate zone of your market and the country forms your regulator uses.

  • Labels and leaflets

    Cartons, labels and patient leaflets in the language or languages your registration needs, on one pack if two are required.

  • Samples

    Samples and reference standards for the regulator's laboratory tests, sent ahead of the first order.

  • Shipping documents

    Invoice, packing list, certificate of origin and the export papers for sea or air freight, on FOB, CFR or CIF terms.

Questions about our markets

Something else? Email [email protected].

Which countries does Progene Pharma export medicines to?

Progene Pharma supplies distributors, importers and tender suppliers in Africa, the Middle East, Southeast Asia, Latin America, North America and Europe. If your country is not named on this page, ask us: the documents are similar in most markets and we will tell you what yours needs.

Do you register medicines with the local regulator for us?

No. In nearly every country a medicine is registered to a licensed local company, usually the importer or distributor, which files with the regulator. Progene Pharma prepares the dossier, the certificates and the samples, and answers the regulator's questions with you.

Who manufactures the medicines?

We manufacture them in a WHO-GMP certified facility in India, which also holds EU-GMP and ISO certification.

Can the packs be labelled in my language?

Yes. Progene Pharma prints cartons, labels and patient leaflets in English, French, Spanish, Portuguese, Arabic or another language your market needs, to match your registration.

Can you supply public tenders?

Yes. Progene Pharma supplies tender packs and the documents tenders usually ask for. Send us the tender requirements and we will confirm what we can provide.

How do I get a quotation?

Send the product, strength, pack size, quantity and destination country by email or WhatsApp. Progene Pharma replies with a quotation, the documents available and the time to ship.

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Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

Request a quote Chat on WhatsApp
Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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