Suppliers / Gland Chemicals

Gland Chemicals

India Updated 9 July 2026

The public registers hold a second record for Gland Chemicals. The fuller profile, with 75 active US DMFs and 3 valid CEPs, is at Gland Pharma. Figures on this page cover only this record.

Gland Chemicals is an API manufacturer based in India. It holds 6 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by CDSCO (India). Customs aggregates show $160K of exports covering 25 molecules to 5 destinations in 2025.

6
active US DMFs
0
valid CEPs
3
registered plants
0
filings across 0 regulators

Registered plants

Site FDA FEI
Kancheepuram, India Not on file
kolar, India Not on file
Malur, India Not on file

What they file, and where

Molecule Regulators Docs
Bortezomib SFDA (Saudi Arabia), US FDA 2
Pemetrexed SFDA (Saudi Arabia), US FDA 2
Dexmedetomidine SFDA (Saudi Arabia) 1
Ertapenem US FDA 1
Gemcitabine US FDA 1
Meropenem US FDA 1
Rocuronium US FDA 1

Also appears on these molecule pages

Bortezomib API Dexmedetomidine API Ertapenem API Gemcitabine API Meropenem API Pemetrexed API Rocuronium API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 4

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $51K 3
2025 Not reported $160K 5
2024 Not reported $43K 3
2023 Not reported $122K 5

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Gland Chemicals

Does Gland Chemicals hold a US DMF or a CEP?
Gland Chemicals holds 6 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 Gland Chemicals manufacture?
3 registered sites are on record, in India (Kancheepuram, Kolar and Malur). Every site is listed on this page with the register it came from.
What does Gland Chemicals make?
7 molecules are on record against Gland Chemicals, including Bortezomib, Pemetrexed, Dexmedetomidine and Ertapenem. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gland Chemicals'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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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
Customs aggregates
Export values, molecule and destination counts