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List of Drug Master Files (KDMF) for Glimepiride Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 USV LIMITED. (1)

02 Medichem S.A. (1)

03 Cadila Healthcare Limited (4)

04 Estec Pharma Co., Ltd. (1)

05 Glenmark Life Sciences Limited (6)

06 Hana Pharmaceutical Co., Ltd. (1)

07 Hetero Drugs Limited@[Starting Material Factory 1]_x000D_ Modepro India (p)Ltd_x000D_ @[Starting Material Factory 2]_x000D_ Medilux Laboratories Pvt. Ltd@[Starting material manufacturing plant 3]_x000D_ Cangzhou senary chemicals & T.CO., Ltd (1)

08 IPCA Laboratories Limited (5)

09 Inist ST Co., Ltd. (1)

10 Ipca Laboratories Limited (1)

11 Leeyeon Pharmaceutical Co., Ltd. (1)

12 ST Pharm Co., Ltd. (1)

13 ST Pharm Co., Ltd. @ [Powder manufacturer] Shandong Xinhua Pharmaceutical co., Ltd (1)

14 Sharon Bio-Medicine Ltd. (1)

15 Shinpoong Pharmaceutical Co., Ltd. (1)

16 Zydus Lifesciences Limited (4)

17 Zydus Lifesciences Limited@Hwail Pharmaceutical Co., Ltd. (1)

18 [Partial process consignment manufacturing (manufacturing requester)] Dasan Pharmaceutical Co., Ltd. @ Myungmoon Bio Co., Ltd. (1)

19 [Second Law Manufacturing Factory] Rini Life Science Pvt, Ltd.@Hanseochem Co., Ltd. (1)

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01 Daesin Pharmaceutical Co., Ltd. (3)

02 Daewon Pharmaceutical Co., Ltd. (1)

03 Darim Biotech Co., Ltd. (1)

04 Dasan Pharmaceutical Co., Ltd. (1)

05 Docheo Co., Ltd. (1)

06 Farm East Co., Ltd. (1)

07 Geonil Pharmaceutical Co., Ltd. (1)

08 Goodwills Co., Ltd. (1)

09 HK Innoen Co., Ltd. (1)

10 Hana Pharmaceutical Co., Ltd. (1)

11 Hanall Biopharma Co., Ltd. (1)

12 Hanseochem Co., Ltd. (1)

13 Hwail Pharmaceutical Co., Ltd. (1)

14 IMCD Korea Co., Ltd. (3)

15 Inist ST Co., Ltd. (1)

16 Kookjeon Pharmaceutical Co., Ltd. (1)

17 Leeyeon Pharmaceutical Co., Ltd. (1)

18 Pharmapia Co., Ltd. (2)

19 ST Pharm Co., Ltd. (2)

20 STech Pharma Co., Ltd. (1)

21 Sangjin Trading Co., Ltd. (1)

22 Seongui Bio Co., Ltd. (1)

23 Shinpoong Pharmaceutical Co., Ltd. (1)

24 Sinpo Farm Co., Ltd. (1)

25 Sungjin Exim Co., Ltd. (1)

26 Sungwoo Chemical Co., Ltd. (1)

27 Wonpoong Pharmaceutical Co., Ltd. (1)

28 Yebong NCP Co., Ltd. (1)

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01 glimepiride (34)

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01 India (24)

02 South Korea (8)

03 Spain (1)

04 Blank (1)

Sinpo Farm Co., Ltd.
2011-03-15
20110315-78-D-89-15
USV LIMITED.
India
B-1/8,MIDC,Lote,Parshuram...
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Pharmapia Co., Ltd.
2007-12-28
20071228-78-D-30-09
Medichem S.A.
Spain
Pollgono Industrial de Ce...
URL Supplier Web Content
Dasan Pharmaceutical Co., Ltd.
2013-10-29
20131029-78-D-129-19
[Partial process consignm...
South Korea
342 Deogamsan-ro, Dogo-my...
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Seongui Bio Co., Ltd.
2015-08-10
20150810-78-D-136-20
Hetero Drugs Limited@[Sta...
India
Sy. No. 213, 214 & 255, B...
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ST Pharm Co., Ltd.
2018-11-09
20181109-78-D-151-21
ST Pharm Co., Ltd. @ [Pow...
South Korea
171 Haean-ro, Danwon-gu, ...
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Daewon Pharmaceutical Co., Ltd.
2015-09-07
20070928-78-D-23-07(7)
Zydus Lifesciences Limite...
India
291, GIDC Estate, Anklesh...
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Daesin Pharmaceutical Co., Ltd.
2021-07-21
20070928-78-D-23-07(9)
Cadila Healthcare Limited
India
291, GIDC, Industrial Est...
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Yebong NCP Co., Ltd.
2013-11-08
20070928-78-D-23-07(6)
Cadila Healthcare Limited
India
291, GIDC Industrial Esta...
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Farm East Co., Ltd.
2023-03-09
20070928-78-D-23-07(10)
Cadila Healthcare Limited
India
291,GIDC Industrial Estat...
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IMCD Korea Co., Ltd.
2017-05-31
20070928-78-D-23-07(8)
Cadila Healthcare Limited
India
291, GIDC Industrial Esta...
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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.

Glimepiride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Glimepiride Drug Master File in Korea (Glimepiride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glimepiride. The MFDS reviews the Glimepiride KDMF as part of the drug registration process and uses the information provided in the Glimepiride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Glimepiride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Glimepiride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Glimepiride suppliers with KDMF on PharmaCompass.

Glimepiride Manufacturers | Traders | Suppliers

Glimepiride Manufacturers, Traders, Suppliers 1
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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