01 1ALP Pharm
01 1(-)-ACYLFULVENE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36863
Submission : 2022-03-03
Status : Active
Type : II
A Irofulven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irofulven, including repackagers and relabelers. The FDA regulates Irofulven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irofulven 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 Irofulven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irofulven supplier is an individual or a company that provides Irofulven active pharmaceutical ingredient (API) or Irofulven finished formulations upon request. The Irofulven suppliers may include Irofulven API manufacturers, exporters, distributors and traders.
click here to find a list of Irofulven suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irofulven DMF (Drug Master File) is a document detailing the whole manufacturing process of Irofulven active pharmaceutical ingredient (API) in detail. Different forms of Irofulven DMFs exist exist since differing nations have different regulations, such as Irofulven USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Irofulven DMF submitted to regulatory agencies in the US is known as a USDMF. Irofulven USDMF includes data on Irofulven's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Irofulven USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Irofulven suppliers with USDMF on PharmaCompass.
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