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

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01 AUROBINDO PHARMA LTD. (2)

02 Akums Lifesciences Limited (1)

03 Apitoria Pharma Private Limited (1)

04 Covalent Laboratories Pvt. Ltd. (3)

05 Daewoong Bio Co., Ltd. (1)

06 Hanmi Fine Chemical Co., Ltd. (1)

07 Orchid Chemicals & Pharmaceuticals Ltd. (1)

08 Orchid Chemicals & Pharmaceuticals Ltd., (1)

09 Orchid Pharma Limited (3)

10 Orchid Pharma Ltd (1)

11 Orchid Pharma Ltd. (1)

12 Qilu Antibiotics Pharmaceutical Co., Ltd (1)

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01 Daewoong Bio Co., Ltd. (1)

02 Donga ST Co., Ltd. (1)

03 Hanareum Farm Co., Ltd. (1)

04 Hanmi Fine Chemical Co., Ltd. (1)

05 KR Farm Co., Ltd. (3)

06 Kukje Pharmaceutical Co., Ltd. (2)

07 Samo Pharmaceutical Co., Ltd. (2)

08 Seongui Bio Co., Ltd. (2)

09 Shinpoong Pharmaceutical Co., Ltd. (1)

10 Sungwoo Chemical Co., Ltd. (1)

11 Withers Pharmaceutical Co., Ltd. (2)

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01 Cefixime (1)

02 Sepixim Cargo (16)

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01 China (1)

02 Egypt (2)

03 India (12)

04 South Korea (2)

URL Supplier Web Content
Kukje Pharmaceutical Co., Ltd.
2015-08-11
20050831-26-A-57-04(3)
AUROBINDO PHARMA LTD.
India
Plot No. 79-91, IDA Chemi...
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Samo Pharmaceutical Co., Ltd.
2022-01-26
20220126-26-A-370-11
Apitoria Pharma Private L...
India
Sy Nos. 52, 53, 58, 59, 6...
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Hanareum Farm Co., Ltd.
2016-06-09
20130710-26-A-286-09(1)
Covalent Laboratories Pvt...
India
Sy.No.374, Gundla Machano...
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KR Farm Co., Ltd.
2013-07-10
20130710-26-A-286-09
Covalent Laboratories Pvt...
India
Sy.No.374, Gundla Machano...
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Withers Pharmaceutical Co., Ltd.
2016-08-09
20130710-26-A-286-09(2)
Covalent Laboratories Pvt...
India
Sy.No.374, Gundla Machano...
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Kukje Pharmaceutical Co., Ltd.
2012-05-18
20050831-26-A-56-03(4)
Orchid Chemicals & Pharma...
India
138-149, SIDCO Industrial...
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KR Farm Co., Ltd.
2012-04-06
20050831-26-A-56-03(5)
Orchid Pharma Ltd.
India
Plot Nos. 121-128, 128A-1...
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Seongui Bio Co., Ltd.
2022-05-31
20050831-26-A-56-03(6)
Orchid Pharma Limited
India
Plot No's. 121-128, 128A-...
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Sungwoo Chemical Co., Ltd.
2012-08-31
20120831-26-A-269-08
Akums Lifesciences Limite...
India
Village Sundhran, Post of...
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Seongui Bio Co., Ltd.
2015-05-15
20150515-26-A-318-10
Qilu Antibiotics Pharmace...
China
No.849 Dongjia Town, Lich...
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Looking for 97164-56-2 / Cefixime API manufacturers, exporters & distributors?

Cefixime manufacturers, exporters & distributors 1

95

PharmaCompass offers a list of Cefixime 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 Cefixime manufacturer or Cefixime supplier for your needs.

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

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

API | Excipient name

Cefixime

Synonyms

97164-56-2, 79350-37-1, Cefixime(e)-form, (e)-cefixime, Cefixime anhydrous, (e)-, U7rwt9j78o

Cas Number

97164-56-2

Unique Ingredient Identifier (UNII)

U7RWT9J78O

About Cefixime

A third-generation cephalosporin antibiotic that is stable to hydrolysis by beta-lactamases.

Cefixime Manufacturers

A Cefixime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefixime, including repackagers and relabelers. The FDA regulates Cefixime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefixime 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 Cefixime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cefixime Suppliers

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

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

Cefixime KDMF

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

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

After submitting a Cefixime 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 Cefixime API can apply through the Korea Drug Master File (KDMF).