Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1MSN Laboratories
03 1Procos
01 3LOFEXIDINE HYDROCHLORIDE
01 1India
02 1Italy
03 1Spain
01 3Active
01 3Complete
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-15
Pay. Date : 2023-07-17
DMF Number : 37978
Submission : 2023-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-30
Pay. Date : 2023-01-23
DMF Number : 34636
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-23
Pay. Date : 2022-12-13
DMF Number : 37543
Submission : 2022-10-25
Status : Active
Type : II
A Lofexidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lofexidine, including repackagers and relabelers. The FDA regulates Lofexidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lofexidine 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 Lofexidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lofexidine supplier is an individual or a company that provides Lofexidine active pharmaceutical ingredient (API) or Lofexidine finished formulations upon request. The Lofexidine suppliers may include Lofexidine API manufacturers, exporters, distributors and traders.
click here to find a list of Lofexidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lofexidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lofexidine active pharmaceutical ingredient (API) in detail. Different forms of Lofexidine DMFs exist exist since differing nations have different regulations, such as Lofexidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lofexidine DMF submitted to regulatory agencies in the US is known as a USDMF. Lofexidine USDMF includes data on Lofexidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lofexidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lofexidine suppliers with USDMF on PharmaCompass.
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