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01 1Cambrex Corporation
02 1F.I.S. Fabbrica Italiana Sintetici
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01 1MIDAZOLAM HCI
02 1MIDAZOLAM HYDROCHLORIDE
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01 1Italy
02 1U.S.A
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01 2Active
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01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39991
Submission : 2024-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-29
Pay. Date : 2018-02-20
DMF Number : 25204
Submission : 2011-08-01
Status : Active
Type : II
A Midazolam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midazolam Hydrochloride, including repackagers and relabelers. The FDA regulates Midazolam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midazolam 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 Midazolam Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Midazolam Hydrochloride supplier is an individual or a company that provides Midazolam Hydrochloride active pharmaceutical ingredient (API) or Midazolam Hydrochloride finished formulations upon request. The Midazolam Hydrochloride suppliers may include Midazolam Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Midazolam Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Midazolam Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Midazolam Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Midazolam Hydrochloride DMFs exist exist since differing nations have different regulations, such as Midazolam Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Midazolam Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Midazolam Hydrochloride USDMF includes data on Midazolam Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Midazolam Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Midazolam Hydrochloride suppliers with USDMF on PharmaCompass.
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