01 1Zhejiang Huida Biotech
01 1PLITIDEPSIN
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39077
Submission : 2023-11-23
Status : Active
Type : II
A Plitidepsin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Plitidepsin, including repackagers and relabelers. The FDA regulates Plitidepsin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Plitidepsin 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 Plitidepsin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Plitidepsin supplier is an individual or a company that provides Plitidepsin active pharmaceutical ingredient (API) or Plitidepsin finished formulations upon request. The Plitidepsin suppliers may include Plitidepsin API manufacturers, exporters, distributors and traders.
click here to find a list of Plitidepsin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Plitidepsin DMF (Drug Master File) is a document detailing the whole manufacturing process of Plitidepsin active pharmaceutical ingredient (API) in detail. Different forms of Plitidepsin DMFs exist exist since differing nations have different regulations, such as Plitidepsin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Plitidepsin DMF submitted to regulatory agencies in the US is known as a USDMF. Plitidepsin USDMF includes data on Plitidepsin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Plitidepsin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Plitidepsin suppliers with USDMF on PharmaCompass.
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