Suppliers / Shilpa Pharma Lifesciences

Shilpa Pharma Lifesciences

India 247 employees Updated 9 July 2026

Shilpa Pharma Lifesciences is an API manufacturer based in India. It holds 53 active US drug master files and 27 valid CEPs. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as NAI. Customs aggregates show $56.3M of exports covering 639 molecules to 58 destinations in 2025.

53
active US DMFs
27
valid CEPs
4
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 March 2025 NAI US FDA
  • 7 March 2025 VAI US FDA
  • 7 February 2020 NAI US FDA
  • 26 July 2019 VAI US FDA
  • 16 December 2016 VAI US FDA
  • 9 March 2015 VAI US FDA
  • 3 May 2013 OAI US FDA

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

Registered plants

Site FDA FEI
Raichur, India 3007197995
Raichur, India 3025560903
Raichur, India Not on file
Raichur, India Not on file

What they file, and where

Molecule Regulators Docs
Busulfan EDQM, SFDA (Saudi Arabia), US FDA 3
Capecitabine EDQM, SFDA (Saudi Arabia), US FDA 3
Cyclophosphamide EDQM, SFDA (Saudi Arabia), US FDA 3
Gemcitabine EDQM, US FDA 3
Imatinib SFDA (Saudi Arabia), US FDA 3
Methotrexate EDQM, US FDA 3
Pirfenidone EDQM, SFDA (Saudi Arabia), US FDA 3
Ursodeoxycholic Acid EDQM, US FDA 3
Ambroxol EDQM, SFDA (Saudi Arabia) 2
Axitinib SFDA (Saudi Arabia), US FDA 2
Show all 30 molecules on file
Bendamustine SFDA (Saudi Arabia), US FDA 2
Bortezomib US FDA 2
Desmopressin EDQM, US FDA 2
Fingolimod EDQM, US FDA 2
Ibrutinib SFDA (Saudi Arabia), US FDA 2
Irinotecan SFDA (Saudi Arabia), US FDA 2
Irinotecan Hydrochloride Trihydrate EDQM 2
Letrozole EDQM, US FDA 2
Nilotinib SFDA (Saudi Arabia), US FDA 2
Octreotide EDQM, US FDA 2
Oxaliplatin EDQM, US FDA 2
Pemetrexed US FDA 2
Pomalidomide SFDA (Saudi Arabia), US FDA 2
Temozolomide EDQM, US FDA 2
Teriflunomide EDQM, US FDA 2
Varenicline SFDA (Saudi Arabia), US FDA 2
Zoledronic Acid EDQM, US FDA 2
Abiraterone US FDA 1
Anastrozole US FDA 1
Azacitidine US FDA 1

Also appears on these molecule pages

Ambroxol contract manufacturing Azacitidine contract manufacturing Bicalutamide contract manufacturing Capecitabine contract manufacturing Lenalidomide contract manufacturing Letrozole contract manufacturing Liraglutide API Montelukast API Nifedipine contract manufacturing Oxcarbazepine API Paclitaxel contract manufacturing Phenylephrine API
Show 2 more molecule pages
Prucalopride contract manufacturing Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 4
US FDA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.4M 29
2025 Not reported $56.3M 58
2024 Not reported $104.4M 50
2023 Not reported $25.3M 51

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

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Open risk flags

  • The most recent inspection outcome was NAI, on 14 March 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