Suppliers / Artemis Biotech

Artemis Biotech

India Updated 9 July 2026

Artemis Biotech is an API manufacturer based in India. It holds one valid CEP. Its GMP standing is certified by EMA.

0
active US DMFs
1
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Hyderabad, India Not on file
Hyderabad, India Not on file
Hyderabad, India 3005000147

What they file, and where

Molecule Regulators Docs
Simvastatin EDQM, SFDA (Saudi Arabia) 2

Also appears on these molecule pages

Simvastatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Artemis Biotech

Does Artemis Biotech hold a US DMF or a CEP?
Artemis Biotech holds 1 valid CEP. 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 Artemis Biotech FDA-registered?
One site operated by Artemis Biotech carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Artemis Biotech manufacture?
3 registered sites are on record, in India (Hyderabad among others). Every site is listed on this page with the register it came from.
What does Artemis Biotech make?
1 molecule is on record against Artemis Biotech, including Simvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Artemis Biotech's GMP?
Current GMP certificates are on record from EMA. 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