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 78 more molecule pages
Bortezomib API Bosentan finished dose Busulfan finished dose Cabozantinib API Carfilzomib finished dose Carisoprodol finished dose Carmustine API Cetirizine finished dose Chlorthalidone finished dose Citalopram API Clonidine finished dose Desmopressin finished dose Eltrombopag finished dose Emtricitabine finished dose Eribulin API Erlotinib API Escitalopram finished dose Etodolac finished dose Etoposide finished dose Everolimus API Famciclovir finished dose Finasteride finished dose Flurbiprofen finished dose Gefitinib API Glatiramer API Glibenclamide finished dose Glyburide finished dose Granisetron API Ibandronate API Ibandronic Acid API Ibrutinib API Imatinib API Imatinib Mesilate API Lansoprazole API Lanthanum Carbonate API Lenalidomide finished dose Letrozole API Lurbinectedin API Modafinil finished dose Molnupiravir finished dose Montelukast finished dose Nadolol finished dose Nilotinib API Nusinersen API Olaparib finished dose Omeprazole API Ondansetron API Oseltamivir finished dose Paclitaxel finished dose Palbociclib finished dose Pantoprazole API Pemetrexed finished dose Pomalidomide API Pregabalin finished dose Risperidone finished dose Rizatriptan API Ruxolitinib API Salmeterol API Semaglutide finished dose Sertraline API Sitagliptin finished dose Sofosbuvir finished dose Sorafenib API Sugammadex API Sumatriptan API Sunitinib finished dose Tenofovir Alafenamide finished dose Tenofovir Disoproxil finished dose Teriflunomide API Thiotepa API Tipiracil API Trabectedin API Trazodone finished dose Trifluridine API Venetoclax API Zidovudine finished dose Zoledronic Acid API Zolmitriptan API

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.

Questions about Natco Pharma

Does Natco Pharma hold a US DMF or a CEP?
Natco Pharma holds 102 active US drug master files and 12 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Natco Pharma FDA-registered?
5 sites operated by Natco Pharma carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Natco Pharma's last inspection go?
The most recent inspection on record closed on 21 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Natco Pharma manufacture?
10 registered sites are on record, in India and United States (Anakapalli, Chennai and Rangareddy among others). Every site is listed on this page with the register it came from.
What does Natco Pharma make?
30 molecules are on record against Natco Pharma, including Letrozole, Ondansetron, Rizatriptan and Sumatriptan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Natco Pharma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, US FDA, CDSCO (India), HSA (SG) and 2 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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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.

Comparable suppliers

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

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