Key facts
- India exported US$4,870 million of bulk drugs & drug intermediates in FY2024-25 (pharmexcil.com).
- Largest destinations by value: unavailable by country
- 1 production cluster mapped, in Andhra Pradesh; Telangana; Karnataka; MP.
- Market guides for 19 countries, each with destination requirements and transit times.
- Certifications available from the supply base: ISO 9001, ISO 14001, WHO-GMP, US FDA registration / approval, EU GMP and more.
- Typical minimum order: Commercial lots from 25 kg for high-value APIs; 1-5 MT for high-volume molecules (typical).
Product overview
India exports bulk drugs and intermediates worth about US$4.9 bn (Pharmexcil, FY2024-25), mostly from Telangana (Hyderabad), Gujarat, Maharashtra and Andhra Pradesh (Visakhapatnam). The range runs from off-patent molecules made at very large scale (analgesics, anti-infectives, cardiovascular and anti-diabetic APIs) to niche and late-lifecycle molecules.
Buyers are formulators who need a reliable second source with regulatory documents: a US DMF, a European CEP, or an open/closed DMF for other regulators. Supplier qualification (audit, samples, three validation batches) is part of the sale.
We source against the buyer's specification and change-control needs, and handle samples, CoA review, documents and logistics.
HS note: APIs spread across chapter 29 by chemistry: 2933/2934 heterocyclics, 2935 sulphonamides, 2936 vitamins, 2937 hormones, 2941 antibiotics, 2942 others. Classify per molecule.
Specifications
| Assay | Per monograph, commonly 98.0-102.0% on dried/anhydrous basis (typical) |
|---|---|
| Related substances | Per USP/Ph. Eur./IP monograph or buyer specification (typical) |
| Residual solvents | Within ICH Q3C limits (typical) |
| Nitrosamine risk assessment | Provided on request for relevant molecules (typical) |
| Particle size | Micronised or as-is per buyer specification, e.g. D90 < 10 µm on request (typical) |
Typical commercial values. Final specifications are fixed per contract and verified by lab report or pre-shipment inspection.
Grades & variants
USP / Ph. Eur. / BP / IP
Pharmacopoeial grade with full CoA.
DMF / CEP backed
Grade supported by a US DMF or EDQM CEP for regulated-market formulators.
Intermediates / KSMs
Key starting materials and advanced intermediates for API makers.
Packaging, MOQ & container loading
| Packing | Sizes | Notes |
|---|---|---|
| Fibre drum | 25 kg / 50 kg fibre or HDPE drums with double LDPE liners | nitrogen-flushed or aluminium bags for sensitive APIs |
| Sample | 100 g - 1 kg samples by courier with CoA | — |
Container load (estimate): 20' GP ~6-12 MT in fibre drums depending on bulk density (10 pallets x 4-8 drums) · 40' HC ~12-20 MT, often weight- or pallet-limited. Much API trade moves by air or LCL; some APIs need temperature control
Customisation: Custom particle size, polymorph and packaging; custom synthesis of intermediates via partner plants
Where we source in India
Producing regions and manufacturing clusters our supplier network draws from.
Telangana
Hyderabad, Sangareddy, Medak
Pashamylaram, Bollaram, Jeedimetla
Andhra Pradesh
Visakhapatnam
JN Pharma City, Parawada
Gujarat
Bharuch, Vadodara, Ahmedabad
Ankleshwar, Jhagadia, Panoli
Maharashtra
Raigad, Palghar
Tarapur, Mahad
Market requirements by region
European Union
APIs imported into the EU need a written confirmation from the exporting country's regulator (CDSCO for India) under the Falsified Medicines Directive, and the formulator must qualify the API site (EU-GMP).
United States & Canada
US formulators reference the API maker's Type II DMF in their ANDA; the API site must be FDA-registered and cGMP-compliant. 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.
Other markets
Brazil (ANVISA) and Mexico (COFEPRIS) require API site certification or documentation as part of the formulator's registration; check per molecule.
East Asia
Japan, Korea and China have their own master-file systems (e.g. Japan MF, Korea KDMF); qualification timelines are long.
General guidance, not legal advice. Confirm current requirements with your customs broker or the regulator.
Trade policy note
Some APIs and precursors are NDPS-controlled or SCOMET-listed and need separate authorisation; check DGFT Appendix 3 (SCOMET) per molecule (source: https://www.dgft.gov.in, asOf 2026-11).
Quality control
- • Batch CoA against the agreed specification
- • Pre-shipment sample retained; third-party testing on request
- • Supplier audit support (questionnaire, on-site or virtual)
Certifications available
- • ISO 9001
- • ISO 14001
- • 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
- • Safety data sheet
- • GMP certificate
- • Written confirmation (EU) where applicable
- • DMF letter of access / CEP copy on request
Trade data
| Period | Flow | Value (USD mn) | Status | Source |
|---|---|---|---|---|
| FY2024-25 | India exportsLine: Bulk drugs & drug intermediates (APIs) | 4,870 | verified | pharmexcil.com |
Top destinations: unavailable by country
Export markets
Frequently asked questions
Do you have DMFs or CEPs?
We do not hold DMFs ourselves. We source from manufacturers who hold them and arrange a letter of access or CEP copy for qualified buyers.
Can I get samples before an audit?
Yes. Samples with a CoA are normally sent first, followed by a quality questionnaire, an audit and validation batches.
What packaging do APIs ship in?
Usually 25 kg fibre or HDPE drums with two LDPE liners, sealed and labelled with batch, manufacturing and retest dates.
Who handles regulatory filings?
The formulator or MAH files with its regulator. The API maker provides the DMF/CEP and site documents.
Do you supply intermediates as well?
Yes, key starting materials and advanced intermediates from partner chemical plants, with impurity profiles on request.
Request a quote for Active Pharmaceutical Ingredients (APIs) & Intermediates
Tell us grade, quantity and destination. We reply with options, packaging and pricing on your Incoterm.
