01 1Cambrex Corporation
01 1LORMETAZEPAM
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4195
Submission : 1981-05-11
Status : Active
Type : II
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A Loretam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loretam, including repackagers and relabelers. The FDA regulates Loretam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loretam 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 Loretam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Loretam supplier is an individual or a company that provides Loretam active pharmaceutical ingredient (API) or Loretam finished formulations upon request. The Loretam suppliers may include Loretam API manufacturers, exporters, distributors and traders.
click here to find a list of Loretam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Loretam DMF (Drug Master File) is a document detailing the whole manufacturing process of Loretam active pharmaceutical ingredient (API) in detail. Different forms of Loretam DMFs exist exist since differing nations have different regulations, such as Loretam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loretam DMF submitted to regulatory agencies in the US is known as a USDMF. Loretam USDMF includes data on Loretam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loretam USDMF is kept confidential to protect the manufacturer’s intellectual property.
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