Molecules / Ertapenem / India

Ertapenem API manufacturers in India

CAS 153832-46-3 ATC J01DH03 Updated 9 July 2026
6
India-based manufacturers with an active filing of 10 worldwide
Showing 4 of 6 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Gland Pharma

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for ertapenem, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Solara Active Pharma Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for ertapenem, filing since 2014. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for ertapenem, filing since 2016. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Gland Chemicals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for ertapenem, filing since 2024.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers in India hold filings for ertapenem

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Apitoria PharmaGland Chemicals
Open the full list with a free account

How this list is built

This page filters the worldwide Ertapenem manufacturer list to companies based in India. The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Read the full method.

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All Ertapenem manufacturers

Worldwide 10