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List of all Manufacturers, Suppliers & Exporters of Glimepiride API listed on PharmaCompass with details of regulatory filings

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01 EUROAPI (2)

02 Jai Radhe Sales (1)

03 Dr. Reddy's Laboratories (1)

04 Octavius Pharma Pvt. Ltd (1)

05 Zeon Pharma Industries India Pvt Ltd (1)

06 Zentiva (1)

07 LGM Pharma (1)

08 Emay Pharmaceuticals (1)

09 USV Private Limited (2)

10 Abhilasha Pharma (1)

11 Bazayan & Co (1)

12 CAD Middle East Pharmaceutical Industries LLC (1)

13 CARBOGEN AMCIS AG (1)

14 CHEMO (1)

15 Chongqing Carelife Pharmaceutical Co., Ltd. (1)

16 Daito Pharmaceutical Co.,Ltd. (1)

17 Dishman Carbogen Amcis (2)

18 DongWoo Syntech (1)

19 Enaltec Labs Private Limited (1)

20 Estechpharma (2)

21 Glenmark Life Sciences (2)

22 Glenmark Pharmaceuticals (1)

23 Guangzhou Tosun Pharmaceutical (1)

24 HELM Portugal (1)

25 Hermes Chemical (1)

26 Hetero Drugs (1)

27 Hoventa Pharma (1)

28 Hubei Haosun Pharmaceutical Co., Ltd. (1)

29 IIQUIAP (1)

30 Indoco Remedies Limited (1)

31 Ipca Laboratories (1)

32 Kores India Limited (1)

33 MSN Laboratories (1)

34 Mac-Chem Products (India) Pvt.Ltd (1)

35 Maps Laboratories Private Limited (1)

36 Micro Labs Limited (1)

37 Murli Krishna Pharma (1)

38 NEWEDGE Overseas (1)

39 Nexchem Pharmaceutical Co, ltd (1)

40 Nishchem International Pvt. Ltd (1)

41 Oman Chemicals & Pharmaceuticals LLC (1)

42 Permachem Asia, Ltd (1)

43 Prudence Pharma Chem (1)

44 Rakshit Drugs (1)

45 Recipharm AB (1)

46 SM BIOMED (1)

47 Shandong Xinhua Pharmaceutical (1)

48 Sharon Bio-Medicine Limited (1)

49 Shenzhen Haorui (1)

50 Sun Pharmaceutical Industries Limited (2)

51 Supra Chemicals (1)

52 Urquima S.A. Grupo Uriach (1)

53 Vaishali Pharma Ltd (1)

54 Wanbang Biopharmaceuticals (1)

55 Yangtze River Pharmaceutical Group (1)

56 Zydus Lifesciences (1)

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01 China (8)

02 Czech Republic (1)

03 France (2)

04 India (36)

05 Japan (2)

06 Malaysia (1)

07 Mexico (1)

08 Oman (1)

09 Portugal (1)

10 Saudi Arabia (1)

11 South Korea (3)

12 Spain (2)

13 Sweden (1)

14 Switzerland (1)

15 U.S.A (1)

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01 Active (13)

02 Inactive (4)

03 Blank (45)

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01 Expired (1)

02 Valid (15)

03 Withdrawn by EDQM Failure to CEP procedure (2)

04 Withdrawn by Holder (2)

05 Blank (42)

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01 220MF10181 (1)

02 221MF10076 (1)

03 221MF10077 (1)

04 221MF10121 (1)

05 221MF10122 (1)

06 221MF10129 (1)

07 226MF10075 (1)

08 303MF10169 (1)

09 Blank (54)

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01 WC-0012 (1)

02 WC-0034 (1)

03 WC-0040 (1)

04 WC-0057n (1)

05 WC-0091 (1)

06 WC-0095 (1)

07 WC-0135 (1)

08 WC-0135A (1)

09 WC-0151 (1)

10 WC-0153 (1)

11 WC-0310 (1)

12 WC-0325 (1)

13 WC-0331 (1)

14 WC-0539 (1)

15 WC-304 (1)

16 Blank (47)

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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
37318
R1-CEP 2005-150 - Rev 03
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
GLIMEPIRIDE (PROCESS 2)
Glimepiride
Issue/Submission Date
2022-07-18
2021-12-09
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Jai Radhe Sales

CPhI Japan

Not Confirmed

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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Found WC

Application Number
16983
R1-CEP 2008-072 - Rev 05
Indian CDSCO WC-0034
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
GLIMEPIRIDE USP
Glimepiride
Glimepiride (USP/Ph. Eur.)
Issue/Submission Date
2003-11-26
2022-03-08
2022-06-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
Octavius Pharma

CPhI Japan

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Zeon Pharma Industries India Pvt Ltd Company Banner

CPhI Japan

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R0-CEP 2007-043 - Rev 01
Status
Expired
 
Filing Details
Glimepiride
Issue/Submission Date
2009-03-25
Zentiva Company banner

CPhI Japan

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
16713
CEP 2023-130 - Rev 00
220MF10181
Indian CDSCO WC-0539
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-10-14
Filing Details
GLIMEPIRIDE USP
Glimepiride, Micronised
Glimepiride at Arvind Vithal Gandhi...
Glimepiride Ph. Eur.
Issue/Submission Date
2003-07-18
2023-11-07
2008-07-31
2022-10-14
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R0-CEP 2022-234 - Rev 00
Status
Valid
 
Filing Details
Glimepiride, Process 2
Issue/Submission Date
2022-10-10
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USDMF

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CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Found WC

Application Number
R1-CEP 2006-243 - Rev 05
Indian CDSCO WC-0012
Status
Valid
 
Valid
2025-06-02
Filing Details
Glimepiride
Glimepiride IH/Ph.Eur.l USP
Issue/Submission Date
2022-05-17
2022-06-27
URL Supplier Web Content
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
15882
R1-CEP 2007-035 - Rev 00
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
GLIMEPIRIDE USP
Glimepiride, Micropowder and super ...
Issue/Submission Date
2002-02-13
2014-05-13
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Found WC

Application Number
17656
R1-CEP 2007-156 - Rev 04
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
GLIMEPIRIDE
Glimepiride
Glimepiride (USP/Ph. Eur.)
Issue/Submission Date
2004-09-09
2019-02-27
2022-07-04
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
20037
R1-CEP 2007-036 - Rev 01
226MF10075
Indian CDSCO WC-0091
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
GLIMEPIRIDE USP
Glimepiride
Glimepiride (production only) at 48...
Glimepiride (BP/USP/ Ph.Eur)
Issue/Submission Date
2006-12-19
2019-12-18
2014-04-02
2022-06-08
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USDMF

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CEP/COS

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Japanese DMF

Found JDMF

Written Confirmation

Close WC

Application Number
32319
303MF10169
Status
Active
Fees Paid
N/A
 
Filing Details
GLIMEPIRIDE
Glimepiride at No. 1, Lutai Road, H...
Issue/Submission Date
2017-11-22
2021-11-25
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
32617
Status
Active
Fees Unpaid
N/A
 
Filing Details
GLIMEPIRIDE NON-STERILE BULK DRUG S...
Issue/Submission Date
2018-04-23
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Caution WC

Application Number
22565
CEP 2009-067 - Rev 04
Indian CDSCO WC-0151
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-15
Filing Details
GLIMEPIRIDE USP
Glimepiride
Glimepiride (Ph. Eur./BP/USP)
Issue/Submission Date
2009-01-12
2024-02-05
2019-08-16
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
35761
Status
Active
Fees Paid
N/A
 
Filing Details
GLIMEPIRIDE USP
Issue/Submission Date
2021-03-31
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Found WC

Application Number
17594
CEP 2022-481 - Rev 00
Indian CDSCO WC-0057n
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2025-06-25
Filing Details
GLIMEPIRIDE USP
Glimepiride, Process-II
Glimepiride Ph. Eur./USP/BP
Issue/Submission Date
2004-08-12
2023-09-22
2022-06-07
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
23005
Indian CDSCO WC-0135A
Status
Active
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
GLIMEPIRIDE
Glimepiride BP/USP/EP
Issue/Submission Date
2009-07-27
2019-12-03
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37221
Status
Active
Fees Paid
Reviewed
 
Filing Details
GLIMEPIRIDE USP
Issue/Submission Date
2022-06-30
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USDMF

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CEP/COS

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Application Number
22561
R1-CEP 2009-079 - Rev 00
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
GLIMEPIRIDE
Glimepiride
Issue/Submission Date
2009-02-26
2016-03-17
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USDMF

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CEP/COS

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Application Number
17288
Status
Inactive
Fees Paid
N/A
 
Filing Details
GLIMEPIRIDE
Issue/Submission Date
2004-04-06
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USDMF

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CEP/COS

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Application Number
22436
Status
Inactive
Fees Paid
N/A
 
Filing Details
GLIMEPIRIDE USP
Issue/Submission Date
2009-03-23
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
18396
R1-CEP 2007-017 - Rev 03
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
GLIMEPIRIDE, MICRONISED
Glimepiride
Issue/Submission Date
2005-06-03
2022-06-10
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
R1-CEP 2006-172 - Rev 03
Indian CDSCO WC-0310
Status
Valid
 
Expired
2023-11-23
Filing Details
Glimepiride
Glimepiride (USP)
Issue/Submission Date
2022-11-28
2021-01-08
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R1-CEP 2006-311 - Rev 00
Status
Valid
 
Filing Details
Glimepiride
Issue/Submission Date
2013-01-30
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R1-CEP 2006-202 - Rev 02
221MF10122
Status
Valid
 
Filing Details
Glimepiride
Glimepiride at 500, Sinnae-ro, Geum...
Issue/Submission Date
2016-02-23
2009-06-16
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
R1-CEP 2007-180 - Rev 01
Status
Valid
 
Filing Details
Glimepiride
Issue/Submission Date
2015-04-24
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USDMF

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Application Number
R1-CEP 2009-176 - Rev 01
Status
Withdrawn by Holder
 
Filing Details
Glimepiride
Issue/Submission Date
2017-07-04
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Looking for 93479-97-1 / Glimepiride API manufacturers, exporters & distributors?

Glimepiride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Glimepiride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glimepiride manufacturer or Glimepiride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glimepiride manufacturer or Glimepiride supplier.

PharmaCompass also assists you with knowing the Glimepiride API Price utilized in the formulation of products. Glimepiride API Price is not always fixed or binding as the Glimepiride Price is obtained through a variety of data sources. The Glimepiride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Glimepiride

Synonyms

93479-97-1, Amaryl, Glimepirid, Amarel, Glimepirida, Glimepiridum

Cas Number

93479-97-1

Unique Ingredient Identifier (UNII)

24T6XIR2MZ

About Glimepiride

Glimepiride is a long-acting, third-generation sulfonylurea with hypoglycemic activity. Compared to other generations of sulfonylurea compounds, glimepiride is very potent and has a longer duration of action. This agent is metabolized by CYP2C9 and shows peroxisome proliferator-activated receptor gamma (PPARgamma) agonistic activity.

Glimepiride Manufacturers

A Glimepiride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glimepiride, including repackagers and relabelers. The FDA regulates Glimepiride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glimepiride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Glimepiride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Glimepiride Suppliers

A Glimepiride supplier is an individual or a company that provides Glimepiride active pharmaceutical ingredient (API) or Glimepiride finished formulations upon request. The Glimepiride suppliers may include Glimepiride API manufacturers, exporters, distributors and traders.

click here to find a list of Glimepiride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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