Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1IDT Australia Limited
01 2LOXAPINE BASE
01 1Australia
02 1Spain
01 1Active
02 1Inactive
01 2Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23144
Submission : 2009-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13135
Submission : 1998-08-14
Status : Inactive
Type : II
A Loxapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loxapine, including repackagers and relabelers. The FDA regulates Loxapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loxapine 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 Loxapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loxapine supplier is an individual or a company that provides Loxapine active pharmaceutical ingredient (API) or Loxapine finished formulations upon request. The Loxapine suppliers may include Loxapine API manufacturers, exporters, distributors and traders.
click here to find a list of Loxapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loxapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Loxapine active pharmaceutical ingredient (API) in detail. Different forms of Loxapine DMFs exist exist since differing nations have different regulations, such as Loxapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loxapine DMF submitted to regulatory agencies in the US is known as a USDMF. Loxapine USDMF includes data on Loxapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loxapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loxapine suppliers with USDMF on PharmaCompass.
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