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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lofexidine Hydrochloride, including repackagers and relabelers. The FDA regulates Lofexidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lofexidine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lofexidine Hydrochloride supplier is an individual or a company that provides Lofexidine Hydrochloride active pharmaceutical ingredient (API) or Lofexidine Hydrochloride finished formulations upon request. The Lofexidine Hydrochloride suppliers may include Lofexidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Lofexidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lofexidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Lofexidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Lofexidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Lofexidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lofexidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Lofexidine Hydrochloride USDMF includes data on Lofexidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lofexidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lofexidine Hydrochloride suppliers with USDMF on PharmaCompass.
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