01 1Mallinckrodt Pharmaceuticals
01 1FENTANYL HYDROCHLORIDE
01 1Ireland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14284
Submission : 1999-06-30
Status : Inactive
Type : II
A Fentanyl Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fentanyl Hydrochloride, including repackagers and relabelers. The FDA regulates Fentanyl Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fentanyl 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 Fentanyl Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fentanyl Hydrochloride supplier is an individual or a company that provides Fentanyl Hydrochloride active pharmaceutical ingredient (API) or Fentanyl Hydrochloride finished formulations upon request. The Fentanyl Hydrochloride suppliers may include Fentanyl Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fentanyl Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fentanyl Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fentanyl Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fentanyl Hydrochloride DMFs exist exist since differing nations have different regulations, such as Fentanyl Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fentanyl Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fentanyl Hydrochloride USDMF includes data on Fentanyl Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fentanyl Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fentanyl Hydrochloride suppliers with USDMF on PharmaCompass.
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