01 2ACS DOBFAR SPA
02 1Centrient Pharmaceuticals
03 1Eli Lilly
04 1Lark laboratories
05 1Zhejiang Anglikang Pharmaceutical
06 1elm-plastic GmbH
07 1Blank
01 1CEFALEXIN MONOHYDRATE (NON-STERILE, BULK FORM)
02 6CEPHALEXIN MONOHYDRATE
03 1CEPHALEXIN MONOHYDRATE BULK
01 1China
02 1Germany
03 1India
04 2Italy
05 1Netherlands
06 1U.S.A
07 1Blank
01 3Active
02 5Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-27
DMF Number : 13612
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13588
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2013-01-11
DMF Number : 13210
Submission : 1998-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13385
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14920
Submission : 2000-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13519
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21842
Submission : 2008-07-09
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13534
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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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, 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.
A Prindex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prindex, including repackagers and relabelers. The FDA regulates Prindex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prindex 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 Prindex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Prindex supplier is an individual or a company that provides Prindex active pharmaceutical ingredient (API) or Prindex finished formulations upon request. The Prindex suppliers may include Prindex API manufacturers, exporters, distributors and traders.
click here to find a list of Prindex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Prindex DMF (Drug Master File) is a document detailing the whole manufacturing process of Prindex active pharmaceutical ingredient (API) in detail. Different forms of Prindex DMFs exist exist since differing nations have different regulations, such as Prindex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prindex DMF submitted to regulatory agencies in the US is known as a USDMF. Prindex USDMF includes data on Prindex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prindex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prindex suppliers with USDMF on PharmaCompass.
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