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 3025560903
Raichur, India 3007197995
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

Abiraterone contract manufacturing Ambroxol contract manufacturing Anastrozole contract manufacturing Axitinib contract manufacturing Azacitidine contract manufacturing Bendamustine contract manufacturing Bicalutamide contract manufacturing Bortezomib contract manufacturing Busulfan API Cabazitaxel contract manufacturing Capecitabine contract manufacturing Cladribine contract manufacturing
Show 50 more molecule pages
Clofarabine contract manufacturing Cyclophosphamide API Cytarabine contract manufacturing Dasatinib contract manufacturing Decitabine contract manufacturing Desmopressin API Dimethyl contract manufacturing Docetaxel contract manufacturing Eltrombopag API Enzalutamide contract manufacturing Erlotinib contract manufacturing Fingolimod contract manufacturing Gemcitabine contract manufacturing Glycopyrronium API Ibrutinib API Imatinib contract manufacturing Imatinib Mesilate API Irinotecan contract manufacturing Lenalidomide contract manufacturing Lenvatinib API Letrozole contract manufacturing Liraglutide API Melphalan contract manufacturing Methotrexate API Montelukast API Nifedipine contract manufacturing Nilotinib API Octreotide API Oxaliplatin contract manufacturing Oxcarbazepine API Paclitaxel contract manufacturing Palbociclib API Pemetrexed contract manufacturing Pemetrexed Disodium 2.5-Hydrate API Pemetrexed Disodium Hemipentahydrate API Phenylephrine API Pirfenidone API Pomalidomide API Prucalopride contract manufacturing Regorafenib contract manufacturing Sorafenib contract manufacturing Sunitinib contract manufacturing Temozolomide contract manufacturing Tenofovir Alafenamide API Teriflunomide API Tranexamic Acid API Ursodeoxycholic Acid API Varenicline API Vismodegib contract manufacturing Zoledronic 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.

Questions about Shilpa Pharma Lifesciences

Does Shilpa Pharma Lifesciences hold a US DMF or a CEP?
Shilpa Pharma Lifesciences holds 53 active US drug master files and 27 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 Shilpa Pharma Lifesciences FDA-registered?
2 sites operated by Shilpa Pharma Lifesciences 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 Shilpa Pharma Lifesciences's last inspection go?
The most recent inspection on record closed on 14 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file, of which 1 closed as OAI.
Where does Shilpa Pharma Lifesciences manufacture?
4 registered sites are on record, in India (Raichur among others). Every site is listed on this page with the register it came from.
What does Shilpa Pharma Lifesciences make?
30 molecules are on record against Shilpa Pharma Lifesciences, including Busulfan, Capecitabine, Cyclophosphamide and Gemcitabine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shilpa Pharma Lifesciences's GMP?
Current GMP certificates are on record from CDSCO (India) and US FDA. 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

  • The most recent inspection outcome was NAI, on 14 March 2025.

Comparable suppliers

Hetero shares 36 molecules MSN Laboratories shares 32 molecules Dr Reddy's Laboratories shares 26 molecules Cipla shares 21 molecules Laurus Labs shares 17 molecules

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