At a glance
- Incoterms
- FOB, FCA, CIF, CIP, DAP
India's generic drug formulations export trade
India exported US$22,928.8 mn of drug formulations & biologicals in FY2024-25 according to pharmexcil.com. That statistical line covers more than generic drug formulations; a product-level figure is not published.
Largest destinations by value share: USA 10,515 (all pharma); UK 914; Brazil 778
Export markets we serve
| Market | What matters there | Sea transit from India |
|---|---|---|
| United Arab Emirates | Drug registration (MOHAP / EDE) | 3-6 days |
| Saudi Arabia | Registration (SFDA) | 6-10 days |
| United States | Drug approval & facility (FDA) | 24-30 via Suez; 32-40 via Cape days |
| Canada | General import clearance | 26-34 via Suez; 34-42 via Cape days |
| Germany | GMP & API written confirmation (EMA / national agencies) | 21-27 via Suez; 31-38 via Cape days |
| Netherlands | GMP & API written confirmation (EMA / national agencies) | 18-24 via Suez; 28-35 via Cape days |
| France | GMP & API written confirmation (EMA / national agencies) | 20–25 d to Le Havre; 15–20 d to Marseille-Fos (ASSUMPTION — this file's analyst estimate, not in 06 §F.2: typical liner schedules) |
| Italy | GMP & API written confirmation (EMA / national agencies) | 15–20 d to Genoa/La Spezia via Suez (ASSUMPTION — this file's analyst estimate, not in 06 §F.2: typical liner schedules) |
| Spain | GMP & API written confirmation (EMA / national agencies) | 15–20 d to Valencia/Barcelona/Algeciras via Suez (ASSUMPTION — this file's analyst estimate, not in 06 §F.2: typical liner schedules) |
| Kuwait | General import clearance | 8–12 d to Shuwaikh/Shuaiba, usually via Jebel Ali (ASSUMPTION — this file's analyst estimate, not in 06 §F.2) |
| Oman | General import clearance | 3–5 d Mundra/Nhava Sheva → Sohar/Muscat; 4–6 d Salalah (ASSUMPTION — this file's analyst estimate, not in 06 §F.2) |
| Bahrain | General import clearance | 7–10 d via Jebel Ali/Dammam (ASSUMPTION — this file's analyst estimate, not in 06 §F.2) |
| Qatar | General import clearance | 6–9 d to Hamad Port, often via Jebel Ali/Salalah transhipment (ASSUMPTION — this file's analyst estimate, not in 06 §F.2) |
| South Africa | General import clearance | 12-18 days |
| Kenya | Registration (KEBS / Pharmacy & Poisons Board) | 9-15 days |
| Tanzania | General import clearance | 10–16 d to Dar es Salaam (ASSUMPTION — this file's analyst estimate, not in 06 §F.2) |
| Singapore | General import clearance | 7-12 days |
| Malaysia | Halal (JAKIM) | 8-12 days |
| Indonesia | General import clearance | 11-16 days |
| Vietnam | General import clearance | 11-16 days |
Transit times are typical port-to-port estimates; regulatory items are the main product-specific requirements, not an exhaustive list.
Where generic drug formulations is sourced in India
Telangana — Hyderabad, Medchal-Malkajgiri, Sangareddy. Pashamylaram, Jeedimetla, Genome Valley clusters
Gujarat — Ahmedabad, Vadodara, Bharuch. Ahmedabad-Vadodara-Ankleshwar belt
Himachal Pradesh — Solan. Baddi-Barotiwala-Nalagarh
Maharashtra — Mumbai, Thane, Pune.
Sikkim — East Sikkim.
Typical export specification
| Parameter | Typical value |
|---|---|
| Dosage forms | Tablets (IR, film-coated, ER), hard/soft gelatin capsules, dry syrups, oral liquids, small-volume injectables, ointments (typical range) |
| Pharmacopoeial standard | IP / BP / USP / Ph. Eur. as per the destination registration (typical) |
| Stability data | ICH zone IVb (30°C/75% RH) for hot-humid markets; zone II for temperate (typical) |
| Dossier format | CTD or ACTD; open/closed part DMF for the API where needed (typical) |
| Serialisation | Barcode/track-and-trace per Indian export rules and destination rules (typical) |
Agreed per contract and confirmed by lab report or pre-shipment inspection.
Export documentation
Documents we prepare or arrange for each shipment:
- Commercial invoice
- Packing list
- Bill of lading / airway bill
- Certificate of origin (preferential where an FTA applies)
- Certificate of analysis
- WHO-GMP certificate
- Certificate of Pharmaceutical Product (CoPP)
- Free sale certificate
- Export NOC from CDSCO where the product is unapproved in India
- Product registration copy in the destination (held by MAH/importer)
Frequently asked questions
What is the HS code for generic drug formulations exported from India?
Generic Drug Formulations is usually classified under HS 3004 (Medicaments consisting of mixed or unmixed products, put up in measured doses or packed for retail sale). The 6-digit subheading depends on the active ingredient (e.g. 3004.10 penicillins, 3004.20 other antibiotics, 3004.90 most others). Vaccines and blood products fall under 3002.
Which documents are needed to export generic drug formulations?
Commercial invoice, Packing list, Bill of lading / airway bill, Certificate of origin (preferential where an FTA applies), Certificate of analysis, WHO-GMP certificate, Certificate of Pharmaceutical Product (CoPP). Destination-specific registrations are listed on each market page.
Who registers the medicine in my country?
The marketing-authorisation holder or the importing buyer. We can source the dossier (CTD/ACTD), CoPP, GMP certificates and samples from the manufacturer to support it, but registration in the destination is not our responsibility.
What is a CoPP?
A Certificate of Pharmaceutical Product in the WHO format, issued by the Indian regulator, confirming the product's licence status and the site's GMP compliance. Many regulators ask for it with a registration file.
Can you supply products that are not approved in India?
Only if the manufacturer holds a CDSCO export NOC for that product and the buyer's country has registered it.
Market guides
Get a quote for generic drug formulations
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