Suppliers / Unimark Remedies

Unimark Remedies

India 538 employees Updated 9 July 2026

Unimark Remedies is an API manufacturer based in India. It holds 34 active US drug master files across a filed portfolio of 26 molecules. Its filings concentrate with EMA, INFARMED (PT) and FAMHP (BE). Its GMP standing is certified by CDSCO (India).

34
active US DMFs
0
valid CEPs
1
registered plants
13
filings across 5 regulators

Registered plants

Site FDA FEI
Valsad, India Not on file

What they file, and where

Molecule Regulators Docs
Nitrofurantoin US FDA 4
Cilastatin US FDA 2
Doripenem US FDA 2
Flecainide US FDA 2
Imipenem US FDA 2
Lisinopril SFDA (Saudi Arabia), US FDA 2
Meropenem US FDA 2
Moxifloxacin SFDA (Saudi Arabia), US FDA 2
Ramipril SFDA (Saudi Arabia), US FDA 2
Topiramate US FDA 2
Show all 26 molecules on file
Albendazole US FDA 1
Armodafinil US FDA 1
Benazepril US FDA 1
Buspirone US FDA 1
Cefixime US FDA 1
Cefuroxime US FDA 1
Dronedarone US FDA 1
Lamotrigine US FDA 1
Meloxicam US FDA 1
Monelukast SFDA (Saudi Arabia) 1
Montelukast US FDA 1
Paliperidone US FDA 1
Pimozide US FDA 1
Rizatriptan US FDA 1
Solifenacin Succinate US FDA 1
Tigecycline US FDA 1

Also appears on these molecule pages

Show 12 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 4 None
INFARMED (PT) 3 None
FAMHP (BE) 3 None
Health Canada 2 None
MINSA (CR) 1 None
CDSCO (India) None 2

Questions about Unimark Remedies

Does Unimark Remedies hold a US DMF or a CEP?
Unimark Remedies holds 34 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.
Where does Unimark Remedies manufacture?
1 registered site is on record, in India (Valsad). Every site is listed on this page with the register it came from.
What does Unimark Remedies make?
26 molecules are on record against Unimark Remedies, including Nitrofurantoin, Cilastatin, Doripenem and Flecainide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Unimark Remedies's GMP?
Current GMP certificates are on record from CDSCO (India). 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.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates