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List of Japan Drug Master File (JDMF) for Cephalexin Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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Flag Italy
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218MF10523
Viale Addetta, 4/12, 20067 Tribiano...
2018-04-17
2006-05-18
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220MF10148
Avenida de Antibioticos 59/61 24009...
2008-06-10
2008-06-10
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302MF10062
Kalpataru Inspire, 3rd Floor, Off W...
2020-05-29
2020-05-29
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451-20, Cheonho-dong, Gangdong-gu, ...
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  • CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 15686-71-2 / Cephalexin API manufacturers, exporters & distributors?

Cephalexin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cephalexin

Synonyms

Cefalexin, 15686-71-2, Cephacillin, Keflex, Ceporexin, Cepexin

Cas Number

15686-71-2

Unique Ingredient Identifier (UNII)

5SFF1W6677

About Cephalexin

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 Manufacturers

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

Cephalexin Suppliers

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

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

Cephalexin JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cephalexin Drug Master File in Japan (Cephalexin JDMF) empowers Cephalexin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cephalexin JDMF during the approval evaluation for pharmaceutical products. At the time of Cephalexin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Cephalexin Manufacturers | Traders | Suppliers

Cephalexin Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Cephalexin

Get in contact with the supplier of your choice:

  1. ACS DOBFAR SPA
  2. ADL BioPharma
  3. Lupin Ltd
  4. YUNGJIN PHARM. 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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