Suppliers / Vasudha Pharma Chem

Vasudha Pharma Chem

India 22 employees Updated 9 July 2026

Vasudha Pharma Chem is an API manufacturer based in India. It holds 66 active US drug master files. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as VAI.

66
active US DMFs
0
valid CEPs
4
registered plants 3 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 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

  • 12 September 2025 VAI US FDA
  • 14 March 2025 VAI US FDA
  • 13 September 2024 VAI US FDA
  • 1 November 2019 NAI US FDA
  • 1 June 2018 VAI US FDA
  • 30 November 2017 VAI US FDA
  • 8 September 2017 NAI US FDA
  • 24 April 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Hyderabad, India 3002093078
Anakapalli, India 3012160303
Visakhapatnam, India Not on file
Ankapalli (D), India 3009822397

What they file, and where

Molecule Regulators Docs
Pantoprazole SFDA (Saudi Arabia), US FDA 6
Loratadine SFDA (Saudi Arabia), US FDA 5
Diatrizoate US FDA 4
Fexofenadine SFDA (Saudi Arabia), US FDA 4
Amitriptyline SFDA (Saudi Arabia), US FDA 3
Esomeprazole SFDA (Saudi Arabia), US FDA 3
Ketorolac SFDA (Saudi Arabia), US FDA 3
Losartan SFDA (Saudi Arabia), US FDA 3
Aripiprazole US FDA 2
Cisapride US FDA 2
Show all 30 molecules on file
Clopidogrel US FDA 2
Cyclobenzaprine US FDA 2
Cyproheptadine US FDA 2
Desloratadine US FDA 2
Diltiazem US FDA 2
Donepezil US FDA 2
Itraconazole US FDA 2
Levetiracetam US FDA 2
Loperamide US FDA 2
Mirabegron US FDA 2
Nortriptyline US FDA 2
Olmesartan US FDA 2
Pimozide US FDA 2
Pregabalin US FDA 2
Quetiapine US FDA 2
Rivaroxaban US FDA 2
Rupatadine US FDA 2
Tamsulosin US FDA 2
Telmisartan US FDA 2
Trazodone US FDA 2

Also appears on these molecule pages

Amitriptyline API Clopidogrel API Cyclobenzaprine API Desloratadine API Diltiazem API Dimethyl contract manufacturing Domperidone API Donepezil API Fexofenadine API Itraconazole API Ketorolac Tromethamine API Loperamide API
Show 16 more molecule pages
Loratadine API Losartan API Nortriptyline API Olmesartan API Pantoprazole API Pregabalin API Rupatadine API Tamsulosin API Telmisartan API Trazodone API Quetiapine API Esomeprazole API Levetiracetam API Rivaroxaban API Mirabegron API Aripiprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EMA None 3
US FDA None 3

Questions about Vasudha Pharma Chem

Does Vasudha Pharma Chem hold a US DMF or a CEP?
Vasudha Pharma Chem holds 66 active US drug master files. 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 Vasudha Pharma Chem FDA-registered?
3 sites operated by Vasudha Pharma Chem 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 Vasudha Pharma Chem's last inspection go?
The most recent inspection on record closed on 12 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Vasudha Pharma Chem manufacture?
4 registered sites are on record, in India (Hyderabad, Anakapalli and Visakhapatnam among others). Every site is listed on this page with the register it came from.
What does Vasudha Pharma Chem make?
30 molecules are on record against Vasudha Pharma Chem, including Pantoprazole, Loratadine, Diatrizoate and Fexofenadine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Vasudha Pharma Chem's GMP?
Current GMP certificates are on record from EMA 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 12 September 2025.

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Hetero shares 11 molecules Zydus Lifesciences shares 10 molecules Apitoria Pharma shares 9 molecules Dr Reddy's Laboratories shares 9 molecules Macleods Pharmaceuticals shares 9 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