Suppliers / Ra Chem Pharma

Ra Chem Pharma

India 382 employees 2 duplicate records merged Updated 9 July 2026

Ra Chem Pharma is an API manufacturer based in India. It holds one active US drug master file across a filed portfolio of 8 molecules. Its GMP standing is certified by MHRA (UK).

1
active US DMFs
0
valid CEPs
1
registered plants
2
filings across 1 regulators

Registered plants

Site FDA FEI
HYDERABAD, India Not on file

What they file, and where

Molecule Regulators Docs
Entacapone SFDA (Saudi Arabia) 1
Flurbiprofen US FDA 1
Fomepizole SFDA (Saudi Arabia) 1
Lamotrigine SFDA (Saudi Arabia) 1
Mebeverine SFDA (Saudi Arabia) 1
Midazolam SFDA (Saudi Arabia) 1
Posaconazole SFDA (Saudi Arabia) 1
Tamsulosin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Articaine contract manufacturing Dipyridamole contract manufacturing Doxazosin contract manufacturing Entacapone API Flurbiprofen API Fomepizole API Midazolam API Tamsulosin API Lamotrigine API Posaconazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
JFDA (JO) 2 None
MHRA (UK) None 1

Questions about Ra Chem Pharma

Does Ra Chem Pharma hold a US DMF or a CEP?
Ra Chem Pharma holds 1 active US drug master file. 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 Ra Chem Pharma manufacture?
1 registered site is on record, in India (Hyderabad). Every site is listed on this page with the register it came from.
What does Ra Chem Pharma make?
8 molecules are on record against Ra Chem Pharma, including Entacapone, Flurbiprofen, Fomepizole and Lamotrigine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ra Chem Pharma's GMP?
Current GMP certificates are on record from MHRA (UK). 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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Sources on this page

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