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Pharma & chemicals

Export bulk drugs (apis)

APIs and intermediates from Hyderabad, Visakhapatnam and Gujarat; regulated buyers need DMFs and GMP inspections.

Free to exportHS 2933
HS code
2933
Active pharmaceutical ingredients and intermediates — heterocyclic compounds (2933, 2934), sulphonamides (2935), antibiotics (2941) and other organic compounds (2942).
Export policy
Free to export
Free to export under ITC(HS) Schedule 2 as checked in November 2026. Narcotic drugs, psychotropic substances and precursor chemicals (for example ephedrine and pseudoephedrine) need an export authorisation from the Narcotics Commissioner (Central Bureau of Narcotics), and a few chemicals are on the SCOMET list. Confirm your exact 8-digit line on the DGFT ITC(HS) search before you ship.
Registrations
4
IEC, GST and those below
India’s exports, 2025-26
US$ 7.78 bn
to 169 countries

What is exported

India is a major API supplier, with plants in Telangana (Hyderabad), Andhra Pradesh (Visakhapatnam), Gujarat (Ankleshwar, Vadodara, Ahmedabad), Maharashtra and Himachal Pradesh, and new bulk drug parks are being built. In 2025-26 India exported about US$ 4.4 billion under HS 2933 alone; the USA and Switzerland led, followed by Brazil, China, the Netherlands and Japan. Buyers are formulation makers, who need regulatory filings and GMP proof before they can use your API.

Varieties, grades and forms

  • Antibiotics and anti-infectivesAmoxicillin, cephalosporins, fluoroquinolones (2941, 2942).
  • Cardiovascular and diabetes APIsSartans, statins, gliptins and metformin.
  • Pain and anti-inflammatory APIsParacetamol, ibuprofen and others.
  • Intermediates and KSMsKey starting materials and advanced intermediates for API makers.

Where it is grown or made

  • TelanganaHyderabad — Jeedimetla, Pashamylaram, Bollaram
  • Andhra PradeshVisakhapatnam (JN Pharma City) and Kakinada
  • GujaratAnkleshwar, Vadodara, Ahmedabad and Bharuch
  • Maharashtra and Himachal PradeshTarapur, Aurangabad; Baddi

Export packing

  • APIs in double LDPE bags inside fibre or HDPE drums, sealed and labelled with batch, manufacturing and retest dates.
  • Temperature-sensitive APIs shipped with data loggers; tamper-evident seals on every drum.
  • Certificate of analysis, SDS and the buyer's required regulatory documents with each lot.

Who buys abroad

  • Generic formulation makers
  • Multinational pharma companies (sourcing and contract manufacturing)
  • API traders and distributors
  • Veterinary drug makers

The quality buyers ask for

Pharmacopoeia
Meets IP, BP, USP or Ph. Eur. monograph as the buyer specifies
Assay
Assay within monograph limits (often 98.0–102.0%)
Impurities
Related substances per ICH Q3A; residual solvents per ICH Q3C; elemental impurities per ICH Q3D; nitrosamine risk assessment
Physical
Particle size, polymorph and bulk density as agreed for the formulation
GMP
Manufactured under ICH Q7 GMP for APIs

Certificates

  • Drug manufacturing licenceRequiredState licence for the API, issued under the Drugs and Cosmetics Act.
  • WHO-GMP certificateOften askedAsked for by most non-regulated markets.
  • US DMF and FDA inspectionOften askedNeeded to supply US formulation makers.
  • EDQM CEP or ASMF, plus EU written confirmationOften askedNeeded for APIs used in medicines sold in the EU.
  • CBN export authorisationOften askedFor narcotic drugs, psychotropic substances and controlled precursors.

Shipping, storage and shelf life

Container load

Drums on pallets; most API orders are well below a full container and move as LCL or air cargo.

How it travels

Air for high-value or urgent APIs; sea for larger volumes.

Storage

Store as per the label (often below 25 °C, protected from light and moisture); temperature-controlled where needed.

Shelf life

Set by stability data as a retest date, often two to five years.

What goes on the pack and carton

  • API name, grade (for example USP), batch, manufacturing and retest dates, net weight, storage conditions and maker's name and address.
  • GHS hazard labels where the substance is hazardous; DG marks for transport.
  • Labels must match the DMF/CEP and the buyer's approved supplier details exactly.
Where to get it tested

NABL-accredited pharmaceutical testing labs and CDSCO-approved labs carry out pharmacopoeial and impurity testing (search 'pharmaceuticals' in the NABL directory). Central and State drug testing laboratories handle regulatory samples.

Benefits of exporting this product

Where to register

  • PharmexcilBulk drugs and their intermediates are listed under Pharmexcil in Appendix 2T; take your RCMC from Pharmexcil.pharmexcil.com ↗
  • CDSCO / State Licensing AuthorityManufacturing licence for the API; CDSCO issues the written confirmation that EU importers need for APIs (Directive 2011/62/EU) and WHO-GMP certificates.cdsco.gov.in ↗

Quality and checks

  • US: Drug Master File (DMF) with the FDA and a plant that passes FDA inspection; EU: Certificate of Suitability (CEP) from EDQM or an ASMF, plus the CDSCO written confirmation.
  • Pharmacopoeial compliance (IP, BP, USP, Ph. Eur.), impurity and residual-solvent limits per ICH Q3; nitrosamine risk assessment is now standard.
  • Certificate of analysis for each batch and stability data.
How to start small

A trader can export APIs from a WHO-GMP maker to formulators in less regulated markets (Africa, South-East Asia, Latin America) where a WHO-GMP certificate and an open DMF part are often enough. Start with a few common molecules and ship samples first.

Where new exporters go wrong

  • Shipping a controlled substance or precursor without the CBN export authorisation.
  • Changing the source plant without telling the buyer; their registration is tied to your site.
  • No EU written confirmation — the EU importer cannot release the API.

Documents this product needs

Schemes that apply

Sources (8)
  1. Department of Commerce, Export Import Data Bank — India's exports of HS 2933 by country, 2025-26
  2. DGFT — Appendix 2T: Export Promotion Councils and the products under each
  3. DGFT — ITC(HS) export policy search (Schedule 2) and SCOMET list (Appendix 3)
  4. CDSCO — Central Drugs Standard Control Organisation
  5. Central Bureau of Narcotics — export authorisation for narcotic drugs, psychotropic substances and precursors
  6. US Food and Drug Administration — Drugs
  7. Pharmexcil — official site
  8. PIB — Scaling New Heights: How the PLI Scheme is Reshaping Industries (21 Dec 2024), list of the 14 PLI sectors

Trade data

Indian bulk drugs (apis) exports in numbers

From the Department of Commerce’s TradeStat, country by country. US$, Indian financial years (April–March).

Exports in 2025-26
US$ 7.78 bn
+3.9% a year on average, 2020-21 to 2025-26
Change from 2024-25
↓ -0.6%
US$ 7.83 bn → US$ 7.78 bn
Buyer countries
169
Average export price
US$ 34.58
per kg · 2,24,902 tonnes shipped · US$ 40.98 the year before
United States of America: US$ 621 mnBrazil: US$ 439 mnSwitzerland: US$ 387 mnChina: US$ 323 mnNetherlands: US$ 296 mnJapan: US$ 295 mnGermany: US$ 268 mnSpain: US$ 253 mnBelgium: US$ 237 mnBangladesh: US$ 237 mnSouth Korea: US$ 232 mnTürkiye: US$ 215 mnUnited Kingdom: US$ 176 mnSingapore: US$ 168 mnItaly: US$ 165 mnRussia: US$ 160 mnEgypt: US$ 141 mnMexico: US$ 137 mnFrance: US$ 129 mnCanada: US$ 119 mnUnited Arab Emirates: US$ 118 mnVietnam: US$ 108 mnIreland: US$ 106 mnUnited States of America: US$ 621 mnUnited States of AmericaBrazil: US$ 439 mnBrazilSwitzerland: US$ 387 mnSwitzerlandChina: US$ 323 mnChinaNetherlands: US$ 296 mnJapan: US$ 295 mnGermany: US$ 268 mnGermanySpain: US$ 253 mnSpainBelgium: US$ 237 mnBangladesh: US$ 237 mnSouth Korea: US$ 232 mnTürkiye: US$ 215 mnUnited Kingdom: US$ 176 mnSingapore: US$ 168 mnItaly: US$ 165 mnRussia: US$ 160 mnEgypt: US$ 141 mnMexico: US$ 137 mnFrance: US$ 129 mnCanada: US$ 119 mnUnited Arab Emirates: US$ 118 mnVietnam: US$ 108 mnIreland: US$ 106 mnIndia
Where Indian bulk drugs (apis) goes — among our 80 countries, 2025-26
2020-21: US$ 6.43 bn6.4k2020-212021-22: US$ 6.93 bn6.9k2021-222022-23: US$ 7.2 bn7.2k2022-232023-24: US$ 8.42 bn8.4k2023-242024-25: US$ 7.83 bn7.8k2024-252025-26: US$ 7.78 bn7.8k2025-26
India’s bulk drugs (apis) exports, year by year · US$ million

The price cycle

India’s average export price per kg each year (total value ÷ total quantity). Highest in 2022-23, lowest in 2025-26 — a 30% swing between them. Keep this swing in mind when you quote.

2020-21: US$ 43.09 per kg2021-22: US$ 44.50 per kg2022-23: US$ 44.80 per kg44.802024-25: US$ 40.98 per kg2025-26: US$ 34.58 per kg34.582020-212021-222022-232023-242024-252025-26
Average export price of Indian bulk drugs (apis) · US$ per kg · dotted = year in between not available

What next: a projection from the trend

The past trend carried forward — not a forecast by any authority. Sudden changes in policy, prices or demand are not in it.

2020-21: US$ 6.43 bn2020-212021-22: US$ 6.93 bn2021-222022-23: US$ 7.2 bn2022-232023-24: US$ 8.42 bn2023-242024-25: US$ 7.83 bn2024-252025-26: US$ 7.78 bn2025-262026-27: US$ 8.58 bn (US$ 7.86 bn – US$ 9.36 bn)8.6k2026-272027-28: US$ 8.95 bn (US$ 8.12 bn – US$ 9.86 bn)8.9k2027-28
India’s bulk drugs (apis) exports and projection · hollow bars = projection, line = likely range
By 2027-28: US$ 8.95 bn

Likely range US$ 8.12 bn to US$ 9.86 bn.

Trend
+4.3% a year
Fit (R²)
0.66
Based on
6 years of official figures

Method: a straight line through the logarithm of yearly exports (log-linear regression); range = ±1 standard error.

Biggest buyer countries

By value in 2025-26. Change is against 2024-25.

Name2025-26Change
1United States of AmericaUS$ 621 mn+8.2%
2UnspecifiedUS$ 506 mn+574.2%
3BrazilUS$ 439 mn+21.2%
4SwitzerlandUS$ 387 mn+9.2%
5ChinaUS$ 323 mn-12.3%
6NetherlandsUS$ 296 mn-3%
7JapanUS$ 295 mn+8.9%
8GermanyUS$ 268 mn-3.8%
9SpainUS$ 253 mn-3.3%
10BelgiumUS$ 237 mn+0.5%
11BangladeshUS$ 237 mn+3.7%
12South KoreaUS$ 232 mn-10.3%

Where demand is rising and falling

Only countries that buy at least US$ 1 million or 1% of India’s exports of this product. Change from 2024-25 to 2025-26.

High demand

  1. UnspecifiedUS$ 75.1 mn → US$ 506 mn+574.2%
  2. FinlandUS$ 108 mn → US$ 164 mn+52.3%
  3. BrazilUS$ 362 mn → US$ 439 mn+21.2%
  4. FranceUS$ 111 mn → US$ 129 mn+15.3%

Low demand

  1. SingaporeUS$ 527 mn → US$ 168 mn-68.2%
  2. United KingdomUS$ 329 mn → US$ 176 mn-46.5%
  3. Pakistan IrUS$ 90.4 mn → US$ 58.6 mn-35.2%
  4. GreeceUS$ 92.7 mn → US$ 66.9 mn-27.8%
  5. United Arab EmiratesUS$ 141 mn → US$ 118 mn-16.5%
  6. EgyptUS$ 167 mn → US$ 141 mn-15.4%
  7. CanadaUS$ 139 mn → US$ 119 mn-14.7%
  8. ChinaUS$ 369 mn → US$ 323 mn-12.3%

Which forms sell, and at what price

India’s exports by 8-digit tariff line, 2025-26. Average price = total value ÷ total quantity (TradeStat): the average of every shipment on that line, not the price of any one deal.

Tariff lineValue 2025-26ChangeQuantityAverage price
Others-of-other heterdcyclic cmpnds with nitrogen hetro atom (s) only2933 99 90 · Heterocyclic compounds in headings no. 2933US$ 1.3 bn-13.9%8,198 tonnesUS$ 157.98 per kgwas US$ 217.32
Other diloxanide furoate, cimetidine, famotidine not elsewhere specified2942 00 90 · Organic compounds in chapter 29US$ 1.1 bn-2.2%30,623 tonnesUS$ 35.86 per kgwas US$ 55.36
Other cmpnds containing an unfused pyrdn ring (whether or not hydrgntd ) in structure2933 39 90 · Heterocyclic compounds, containing an unfused pyridine ring in the structure in 2933.3US$ 719 mn-16%21,412 tonnesUS$ 33.60 per kgwas US$ 43.03
Others-of-other heterocyclic compounds2934 99 90 · Nucleic acids and their salts, other heterocyclic compounds in heading number 2934US$ 716 mn+10.8%8,008 tonnesUS$ 89.36 per kgwas US$ 91.73
Other cmpnds containing a pyrimidine ring (whether or not hydrgntd) or piperazine ring in structure2933 59 90 · Heterocyclic compounds, containing a pyrimidine ring or piperazine ring in the structure in 2933.5US$ 700 mn+32.3%7,604 tonnesUS$ 92.07 per kgwas US$ 87.98
Antibiotics in heading no. 2941 — other antibiotics2941 90 90US$ 512 mn-9.3%3,190 tonnesUS$ 160.46 per kgwas US$ 157.62
Others-of-other htrcyclc cmpnds containing an unfused pyrzl ring (whether or not hydrgntd) in the structure2933 19 99 · Heterocyclic compounds, with nitrogen hetero-atom only, containing an unfused pyrazole ring in the…US$ 369 mn+18.6%4,113 tonnesUS$ 89.61 per kgwas US$ 81.36
Others-of-others-of-sulphonamides2935 90 90 · Sulphonamides in heading no. 2935US$ 291 mn+0.1%27,583 tonnesUS$ 10.55 per kgwas US$ 12.26
Other compnds containing an unfused imidazole ring (whether or not hydrgntd ) in structure2933 29 90 · Heterocyclic compounds, with nitrogen hetero-atom only, containing an unfused imidazole ring in the…US$ 235 mn+11.3%4,695 tonnesUS$ 50.10 per kgwas US$ 55.69
Others-of-others-of-heterocyclic compounds with nitrogen2933 49 90 · Heterocyclic compounds, containing a quinoline or isoquinoline ring-system in the structure, not further…US$ 187 mn—3,334 tonnesUS$ 56.01 per kg
Heterocyclic compounds, lactams, other than 6-hexanelactam and clobazam and methyprylon — others-of-other lactams2933 79 90US$ 179 mn-1.1%1,182 tonnesUS$ 151.81 per kgwas US$ 186.58
Others-of-other : derivatives of pyridine :2933 39 29 · Heterocyclic compounds, containing an unfused pyridine ring in the structure in 2933.3US$ 170 mn-6.2%11,779 tonnesUS$ 14.44 per kgwas US$ 16.33
Amoxycilline and its salts2941 10 30 · Antibiotics, penicillins and their derivatives with a penicillanic acid structure, salts thereofUS$ 143 mn-22.1%5,549 tonnesUS$ 25.83 per kgwas US$ 31.44
Erthromycin and its drvtvs slts thereof2941 50 00 · Antibiotics, erythromycin and its derivatives, salts thereofUS$ 94.7 mn-12.1%754 tonnesUS$ 125.62 per kgwas US$ 130.30

The world market

Each country’s own recorded exports and imports in UN Comtrade, 2023 (the latest year nearly every country has reported).

World imports
US$ 167.7 bn
2023
India among exporters
#6
of 123 countries
India’s share of world exports
4.7%
US$ 7.35 bn
Left for others to win
US$ 148.9 bn
exported by other countries

Top exporters — your competitors

  1. 1IrelandUS$ 31 bn 19.9%
  2. 2SwitzerlandUS$ 30.9 bn 19.8%
  3. 3ChinaUS$ 21.7 bn 13.9%
  4. 4USAUS$ 7.84 bn 5%
  5. 5United KingdomUS$ 7.54 bn 4.8%
  6. 6IndiaUS$ 7.35 bn 4.7%
  7. 7SingaporeUS$ 7.08 bn 4.5%
  8. 8FranceUS$ 6.99 bn 4.5%
  9. 9GermanyUS$ 6.43 bn 4.1%
  10. 10AustriaUS$ 6.11 bn 3.9%

Biggest buyers in the world

  1. 1USAUS$ 24.8 bn 14.8%
  2. 2GermanyUS$ 22 bn 13.1%
  3. 3IrelandUS$ 19.3 bn 11.5%
  4. 4SloveniaUS$ 11.2 bn 6.7%
  5. 5ItalyUS$ 10.6 bn 6.3%
  6. 6IndiaUS$ 7.56 bn 4.5%
  7. 7United KingdomUS$ 7.2 bn 4.3%
  8. 8BelgiumUS$ 6.95 bn 4.1%
  9. 9BrazilUS$ 5.32 bn 3.2%
  10. 10SpainUS$ 5.25 bn 3.1%

Opportunity: what these countries buy from the world, and from India

Each country’s own recorded imports in UN Comtrade, latest year it has reported. The long light part of each bar is demand other countries are filling today.

United States of AmericaUS$ 22.3 bnIndia 5.8% · gap US$ 21 bn
GermanyUS$ 19.4 bnIndia 2.6% · gap US$ 18.9 bn
ItalyUS$ 11.8 bnIndia 5.3% · gap US$ 11.2 bn
United KingdomUS$ 7.2 bnIndia 3.3% · gap US$ 6.96 bn
ChinaUS$ 4.18 bnIndia 11.6% · gap US$ 3.7 bn
SpainUS$ 4.17 bnIndia 11.5% · gap US$ 3.69 bn
CanadaUS$ 3.27 bnIndia 4.1% · gap US$ 3.13 bn
FranceUS$ 3.4 bnIndia 8.1% · gap US$ 3.13 bn
JapanUS$ 3.78 bnIndia 18.3% · gap US$ 3.08 bn
South KoreaUS$ 2.46 bnIndia 14.9% · gap US$ 2.09 bn

TradeStat’s 2023-24 quantities are double-counted, so that year is left out of the price. Sources: TradeStat — Export Import Data Bank, Department of Commerce · UN Comtrade database (United Nations Statistics Division) · Figures taken 29 October 2026.

Step by step

How to export bulk drugs (apis)

India is one of the largest API producers and the main supplier of many generic APIs to regulated and emerging markets, with a large number of US FDA-inspected plants. China is the dominant producer of APIs and key starting materials, and Italy, Spain and Switzerland lead in high-value APIs. Demand comes from generic drug makers worldwide and from buyers who want supply chains less dependent on China. Openings are in fermentation-based and complex APIs, intermediates and KSMs supported by the PLI scheme and bulk drug parks, and contract manufacturing.

  1. 01Pick molecules

    Choose APIs where your maker has filings (DMF, CEP, WHO-GMP).

  2. 02Qualify with the buyer

    Send samples, CoA, open part of the DMF and GMP certificates.

  3. 03Audit

    Buyers often audit the plant before approval.

  4. 04Check controls

    NDPS, precursor and SCOMET status of the molecule.

  5. 05Produce and release

    Batch CoA, stability data and EU written confirmation if needed.

  6. 06Ship and claim

    File the shipping bill; claim RoDTEP and drawback.

  7. 07Payment

    Advance or LC with new buyers; established buyers often pay 60–90 days — use ECGC cover.

Meet buyers

Trade fairs

Questions

Questions about exporting bulk drugs (apis)

What is a DMF?
A Drug Master File filed with the US FDA describing how the API is made; the buyer references it in their own drug application.
What is the EU written confirmation?
A statement from CDSCO that the API plant follows GMP equivalent to EU standards; required for API imports into the EU.
Which council?
Pharmexcil (bulk drugs and intermediates).
What RoDTEP applies?
Most API lines in Chapter 29 that we checked carry 0.7–0.8% of FOB.
Do I need a licence for ephedrine?
Yes. Ephedrine, pseudoephedrine and other controlled substances need an export authorisation from the Central Bureau of Narcotics.
Sources (7)
  1. CDSCO — Central Drugs Standard Control Organisation
  2. Central Bureau of Narcotics — export authorisation for narcotic drugs, psychotropic substances and precursors
  3. US Food and Drug Administration — Drugs
  4. Pharmexcil — official site
  5. NABL — search for accredited testing laboratories
  6. DGFT — Appendix 4R, RoDTEP schedule for DTA exports w.e.f. 10.10.2024 (Notification 32/2024-25); rates continued to 31.12.2026 by Notification 41/2026-27
  7. PIB — Scaling New Heights: How the PLI Scheme is Reshaping Industries (21 Dec 2024), list of the 14 PLI sectors

Who buys Indian bulk drugs (apis)

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