Suppliers / Mac Chem Products India

Mac Chem Products India

India Updated 9 July 2026

Mac Chem Products India is an API manufacturer based in India. It appears in 8 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by MFDS (Korea) and EMA.

0
active US DMFs
0
valid CEPs
1
registered plants
8
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Boisar, India Not on file

What they file, and where

Molecule Regulators Docs
Dacarbazine SFDA (Saudi Arabia) 1
Letrozole SFDA (Saudi Arabia) 1
Methotrexate SFDA (Saudi Arabia) 1
Pemetrexed Disodium SFDA (Saudi Arabia) 1
Succinylcholine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

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Fosaprepitant contract manufacturing Gefitinib contract manufacturing Gemcitabine contract manufacturing Hydrocortisone contract manufacturing Imatinib contract manufacturing Irinotecan contract manufacturing Letrozole contract manufacturing Methotrexate contract manufacturing Methylprednisolone contract manufacturing Neostigmine contract manufacturing Omeprazole contract manufacturing Oxaliplatin contract manufacturing Paclitaxel contract manufacturing Palbociclib contract manufacturing Pantoprazole contract manufacturing Pemetrexed contract manufacturing Pemetrexed Disodium API Prednisolone contract manufacturing Propofol contract manufacturing Ropivacaine contract manufacturing Succinylcholine API Temozolomide contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 8 None
MFDS (Korea) None 2
EMA None 1

Questions about Mac Chem Products India

Does Mac Chem Products India hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Mac Chem Products India. It does have 8 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Mac Chem Products India manufacture?
1 registered site is on record, in India (Boisar). Every site is listed on this page with the register it came from.
What does Mac Chem Products India make?
5 molecules are on record against Mac Chem Products India, including Dacarbazine, Letrozole, Methotrexate and Pemetrexed Disodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mac Chem Products India's GMP?
Current GMP certificates are on record from MFDS (Korea) and 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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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