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