Molecules / Glimepiride

Glimepiride API manufacturers

CAS 93479-97-1 ATC A10BB12 Updated 9 July 2026
27
manufacturers with an active filing 14 of them hold a US DMF or a CEP
$468.96
median export price per kg $273.01 to $760.00 · 72 exporters · 2025
62
shortage records on file across 6 countries
834
finished-dose makers across 51 regulators
Showing 20 of 27 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for glimepiride, filing since 2003. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Ipca Laboratories

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

Holds one active US DMF and 2 valid CEPs for glimepiride, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Micro Labs

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

Holds one active US DMF and 2 valid CEPs for glimepiride, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

USV

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

Holds one active US DMF and 2 valid CEPs for glimepiride, filing since 2003. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
FDA, List of Drug Master Files
View profile
05

MSN Life Sciences

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

Holds one active US DMF and one valid CEP for glimepiride, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

Hetero

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

Holds 2 active US DMFs for glimepiride, filing since 2004. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for glimepiride. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Chongqing Carelife Pharmaceutical

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

Holds one active US DMF for glimepiride, filing since 2002. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Sanofi

France
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for glimepiride. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
12

Shandong Xinhua Pharmaceutical

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

Holds 4 active US DMFs for glimepiride, filing since 2017. Its GMP is recognised in 5 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Euroapi France

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

Holds 2 valid CEPs for glimepiride, filing since 2021. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2021 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
EDQM certificate database
View profile
15

EUROAPI Germany

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

Holds one active US DMF for glimepiride, filing since 2022. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Inist St

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

Holds one valid CEP for glimepiride, filing since 2016.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
17

Ampharco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for glimepiride. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Công ty cổ phần dược phẩm SaVi

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for glimepiride. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Iniststco.,Ltd

South Korea
Makes the API

Registered with PMDA (Japan) for glimepiride.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

PolarisAIPharmaCorp

South Korea
Makes the API

Registered with PMDA (Japan) for glimepiride.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

24 more manufacturers hold filings for glimepiride

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

USVMSN Life SciencesAlivus Life SciencesHeteroMedilux LaboratoriesGlenmark Pharmaceuticals s.r.oChongqing Carelife PharmaceuticalSanofiShandong Xinhua PharmaceuticalEuroapi FranceYangtze River Pharmaceutical Group Jiangsu Haici Biological PharmaceuticalEUROAPI GermanyInist StAmpharcoCông ty cổ phần dược phẩm SaViIniststco.,LtdPolarisAIPharmaCorp
Open the full list with a free account

Contract manufacturers (8)

Corona Remedies India Zhejiang Haizhou Pharmaceutical China Acme Generics India Auro Laboratories India Rakshit Drugs India Inist St South Korea Sidefarma Portugal Yangtze River Pharmaceutical Group China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (123)

Inventia Healthcare India Torrent Pharmaceuticals India Cadila Pharmaceuticals India Viatris United States Sandoz Switzerland Zydus Lifesciences India Denk Pharma GmbH Germany Lek Poland Zentiva, k.s Czech Republic Ajanta Pharma India Amneal United States Apotex Canada Genzyme United States HIKMA ITALIA Italy Teva Israel MSN Laboratories India Jetpharma Switzerland Mankind Pharma India Sanofi Winthrop Industrie France STADA Arzneimittel Germany

How this list is built

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. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 4 yrs Shortages 62 Recalls 20 Finished dose 123 Contract mfrs 8

By country

India 13 China 6 South Korea 6

Export price by year

Year Median Exporters
2026 YTD $517.25 32
2025 $468.96 72
2024 $476.71 60
2023 $512.07 54

US dollars per kilogram, customs export unit values.