Key facts
- India exported US$22,929 million of drug formulations & biologicals in FY2024-25 (pharmexcil.com).
- Largest destinations by value: USA 10,515 (all pharma); UK 914; Brazil 778
- Market guides for 28 countries, each with destination requirements and transit times.
- Certifications available from the supply base: ISO 9001, WHO-GMP, US FDA registration / approval, EU GMP, CDSCO licence.
- Typical minimum order: One registered SKU at the manufacturer's minimum batch size, often 50,000-200,000 units per SKU (typical).
Product overview
India is one of the world's largest suppliers of generic medicines by volume. Formulations make up about three-quarters of Indian pharma exports, and the US is the largest single market (Pharmexcil, FY2024-25). Manufacturing is concentrated in Hyderabad, Ahmedabad-Vadodara, Mumbai-Pune, Baddi (Himachal Pradesh), Sikkim and Visakhapatnam.
We treat formulations as a sourcing and trading category. We match a buyer's product list and registration status with WHO-GMP (and, where needed, US FDA or EU-GMP inspected) manufacturers, then handle documents, logistics and pre-shipment checks. A medicine can only be sold in a destination once it is registered there. The marketing-authorisation holder (MAH) or the importing buyer is responsible for that registration, not the trading house.
Most trade is in branded generics and tender supplies to Africa, Latin America, CIS and South-East Asia. Regulated markets (US, EU, UK) need product-specific approvals such as an ANDA or MA, and are served directly by the approved manufacturer.
HS note: 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.
Specifications
| 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) |
Typical commercial values. Final specifications are fixed per contract and verified by lab report or pre-shipment inspection.
Grades & variants
WHO-GMP branded generics
From plants holding WHO-GMP and CoPP issued by Indian regulators; standard for Africa, Asia, CIS tenders and private markets.
PIC/S or EU-GMP inspected
Plants inspected by an EU/PIC/S authority; needed for some semi-regulated tenders and EU/UK supply.
US FDA approved (ANDA)
Products with an approved ANDA, made at FDA-inspected sites; supplied through the ANDA holder.
Donor / institutional tenders
WHO-prequalified or Global Fund-eligible products for UN agency and donor procurement.
Packaging, MOQ & container loading
| Packing | Sizes | Notes |
|---|---|---|
| Blister / strip | Alu-Alu, Alu-PVC/PVDC blisters of 10s in printed cartons | artwork in the destination's language per the registration |
| Bottle | HDPE bottles 30-1,000 count with induction seal and desiccant | — |
| Shipper | 5-ply export cartons on ISPM-15 pallets; cold-chain packs for 2-8°C products | — |
Container load (estimate): 20' GP 10 standard pallets (non-stackable); usually volume-limited · 40' HC 20-21 standard pallets. Many shipments go by air or LCL; temperature-sensitive products need reefer or active containers
Customisation: Distributor-branded packs where the buyer holds the registration; language-specific cartons and leaflets
Where we source in India
Producing regions and manufacturing clusters our supplier network draws from.
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
Market requirements by region
European Union
EU supply needs a marketing authorisation, an EU-GMP compliant site and Qualified Person release in the EU; APIs need a written confirmation from CDSCO.
United States & Canada
US sale needs an approved ANDA/NDA, FDA establishment registration and cGMP compliance; the ANDA holder imports. US duty on Indian goods as of 22 Oct 2026 (per our compliance research, secondary legal analysis): MFN rate plus a 10% Section 301 tariff in force since 24 Jul 2026; Section 232 goods (steel, aluminium, copper, autos/parts) pay the 232 rate instead. Re-verify before quoting landed cost.
Gulf (GCC)
Saudi SFDA and UAE MOHAP/EDE require drug registration plus GMP evidence for the manufacturing site; the registration holder, not the shipper, owns this.
Southeast Asia
Registration is national (e.g. Indonesia BPOM, Malaysia NPRA, Philippines FDA) using ACTD dossiers; Malaysia and Indonesia often require halal for certain excipients such as gelatin capsules.
Africa
Nigeria (NAFDAC), Kenya (Pharmacy and Poisons Board), South Africa (SAHPRA) and others require product registration held by the local MAH/importer before import; Kenya also routes goods through PVoC/PPB checks.
General guidance, not legal advice. Confirm current requirements with your customs broker or the regulator.
Trade policy note
Export NOC from CDSCO (via SUGAM) is required for drugs unapproved, new or banned in India; per research this NOC must precede the state licence, with the transition ending 30 Sep 2026 (source: https://cdscoonline.gov.in, asOf 2026-11). NDPS-controlled molecules need separate authorisation (ASSUMPTION).
Quality control
- • Certificate of analysis per batch from the manufacturer's QC lab
- • Independent testing at an accredited lab on request
- • Pre-shipment check of labels, batch numbers and expiry against the registration
- • Temperature logging for cold-chain cargo
Certifications available
- • ISO 9001
- • WHO-GMP
- • US FDA registration / approval
- • EU GMP
- • CDSCO licence
Held by the producing supplier for the specific lot; copies shared with the quote.
Shipping documents
- • 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)
Trade data
| Period | Flow | Value (USD mn) | Status | Source |
|---|---|---|---|---|
| FY2024-25 | India exportsLine: Drug formulations & biologicals | 22,928.8 | verified | pharmexcil.com |
Top destinations: USA 10,515 (all pharma); UK 914; Brazil 778
Export markets
Frequently asked questions
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.
Do you ship cold-chain products?
Yes, by reefer or air with temperature loggers, under CIP/CFR terms agreed in advance. Vaccines and biologics need validated packaging.
Can you do private-label packs?
Yes, where the buyer holds or is applying for the registration. Artwork must match the registered labelling exactly.
Request a quote for Generic Drug Formulations (Tablets, Capsules, Injectables)
Tell us grade, quantity and destination. We reply with options, packaging and pricing on your Incoterm.
