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

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01 Centrient Pharmaceuticals Spain S.A. (2)

02 Apitoria Pharma Private Limited, Unit-IV (1)

03 Aurobindo Pharma Limited (1)

04 Lupine Ltd. (2)

05 North China Pharmaceutical Co., Ltd. (2)

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01 Aging Life Science Co., Ltd. (1)

02 Dongwha Pharmaceutical Co., Ltd. (1)

03 Korea Chorus Co., Ltd. (1)

04 Masung LS Co., Ltd. (1)

05 Pharmapia Co., Ltd. (2)

06 Seongui Bio Co., Ltd. (1)

07 Yuhan Corporation (1)

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01 Cephalexin hydrate (8)

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01 China (2)

02 India (4)

03 Netherlands (2)

Yuhan Corporation
2015-07-03
20140221-151-I-363-04(1)
Centrient Pharmaceuticals...
Spain
Poligono Industrial Urvas...
Centrient Pharmaceuticals

Iran Expo

Not Confirmed

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Aging Life Science Co., Ltd.
2014-02-21
20140221-151-I-363-04
Centrient Pharmaceuticals...
Spain
C/Ripolles, n2 Poligono I...
Centrient Pharmaceuticals

Iran Expo

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
Seongui Bio Co., Ltd.
2014-11-17
20131107-151-I-316-03(1)
Aurobindo Pharma Limited
India
Unit-XI, Sy. Nos. 1/22, 2...
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Dongwha Pharmaceutical Co., Ltd.
2013-11-07
20131107-151-I-316-03
Apitoria Pharma Private L...
India
Sy. No's. 52, 53, 58, 59,...
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Pharmapia Co., Ltd.
2014-07-25
20130418-151-I-222-01(1)
Lupine Ltd.
India
Unit-1, 198-202, New Indu...
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Masung LS Co., Ltd.
2013-04-18
20130418-151-I-222-01
Lupine Ltd.
India
198-202, New Industrial A...
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Pharmapia Co., Ltd.
2017-12-08
20130516-151-I-332-02(1)
North China Pharmaceutica...
China
No.18 Yangzi Road, ShiJia...
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Korea Chorus Co., Ltd.
2013-05-16
20130516-151-I-332-02
North China Pharmaceutica...
China
No.18 Yangzi Road, ShiJia...
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Looking for 23325-78-2 / Cephalexin Monohydrate API manufacturers, exporters & distributors?

Cephalexin Monohydrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cephalexin Monohydrate

Synonyms

23325-78-2, Cephalexin hydrate, Cefalexin monohydrate, Keflet, Cefalexin hydrate, Palitrex

Cas Number

23325-78-2

Unique Ingredient Identifier (UNII)

OBN7UDS42Y

About Cephalexin Monohydrate

A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.

Cephalexin Monohydrate Manufacturers

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

Cephalexin Monohydrate Suppliers

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

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

Cephalexin Monohydrate KDMF

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

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

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

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

Cephalexin Monohydrate Manufacturers | Traders | Suppliers

Cephalexin Monohydrate Manufacturers, Traders, Suppliers 1
89

We have 4 companies offering Cephalexin Monohydrate

Get in contact with the supplier of your choice:

  1. Centrient Pharmaceuticals
  2. Aurobindo Pharma Limited
  3. Lupin Ltd
  4. North China Pharmaceutical Co., Ltd.
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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