Suppliers / Natco Pharma

Natco Pharma

India NATCOPHARM.BO 2 duplicate records merged Updated 9 July 2026

Natco Pharma is an API and finished-dose manufacturer based in India. It holds 102 active US drug master files and 12 valid CEPs. Its filings concentrate with Health Canada, US FDA and CDSCO (India). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 21 November 2025 as VAI. Customs aggregates show $87.4M of exports covering 1,402 molecules to 55 destinations in 2025.

102
active US DMFs
12
valid CEPs
10
registered plants 5 with an FDA FEI number
456
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 21 November 2025 VAI US FDA
  • 19 June 2025 VAI US FDA
  • 13 June 2025 VAI US FDA
  • 3 February 2023 VAI US FDA
  • 9 August 2019 VAI US FDA
  • 12 July 2019 NAI US FDA
  • 24 June 2019 VAI US FDA
  • 6 June 2019 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Anakapalli, India 3015380536
Chennai, India 3009870595
Rangareddy, India 3004065860
Rangareddy, India 3004540906
RANGAREDDY, India Not on file
Kothur, India Not on file

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Letrozole EDQM, SFDA (Saudi Arabia), US FDA 6
Ondansetron EDQM, SFDA (Saudi Arabia), US FDA 6
Rizatriptan EDQM, US FDA 5
Sumatriptan EDQM, US FDA 5
Anastrozole EDQM, SFDA (Saudi Arabia), US FDA 4
Apixaban SFDA (Saudi Arabia), US FDA 4
Granisetron US FDA 4
Ibandronate US FDA 4
Zoledronic Acid SFDA (Saudi Arabia), US FDA 4
Acalabrutinib SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Bendamustine SFDA (Saudi Arabia), US FDA 3
Capmatinib SFDA (Saudi Arabia), US FDA 3
Cidofovir SFDA (Saudi Arabia), US FDA 3
Citalopram EDQM, US FDA 3
Eribulin SFDA (Saudi Arabia), US FDA 3
Everolimus SFDA (Saudi Arabia), US FDA 3
Gefitinib EDQM, US FDA 3
Ibrutinib SFDA (Saudi Arabia), US FDA 3
Imatinib SFDA (Saudi Arabia), US FDA 3
Omeprazole EDQM, US FDA 3
Pomalidomide SFDA (Saudi Arabia), US FDA 3
Salmeterol EDQM, US FDA 3
Sorafenib SFDA (Saudi Arabia), US FDA 3
Sugammadex SFDA (Saudi Arabia), US FDA 3
Teriflunomide SFDA (Saudi Arabia), US FDA 3
Tipiracil SFDA (Saudi Arabia), US FDA 3
Trifluridine SFDA (Saudi Arabia), US FDA 3
Alectinib US FDA 2
Bortezomib US FDA 2
Cabozantinib US FDA 2

Also appears on these molecule pages

Show 18 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 211 None
US FDA 157 3
CDSCO (India) 24 2
HSA (SG) 16 2
JFDA (JO) 13 None
NCELS (KZ) 11 None
ANVISA (Brazil) None 10
EMA None 5
FDA (GH) None 1
NAFDAC (NG) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $15.8M 27
2025 $517.5M $87.4M 55
2024 $479.5M $62.1M 54
2023 $329.3M $73.4M 57

Export figures are customs aggregates. We do not publish the identity of any buyer.

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Open risk flags

  • 70 active litigation matters are on record.
  • One recent serious compliance event is on record.
  • The most recent inspection outcome was VAI, on 21 November 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts
Company filings
Revenue as reported