01 1Nippon Kayaku
01 1ETOPOSIDE PHOSPHATE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10476
Submission : 1993-09-17
Status : Active
Type : II
A Etoposide Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etoposide Phosphate, including repackagers and relabelers. The FDA regulates Etoposide Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etoposide Phosphate 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 Etoposide Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etoposide Phosphate supplier is an individual or a company that provides Etoposide Phosphate active pharmaceutical ingredient (API) or Etoposide Phosphate finished formulations upon request. The Etoposide Phosphate suppliers may include Etoposide Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Etoposide Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etoposide Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Etoposide Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Etoposide Phosphate DMFs exist exist since differing nations have different regulations, such as Etoposide Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etoposide Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Etoposide Phosphate USDMF includes data on Etoposide Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etoposide Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etoposide Phosphate suppliers with USDMF on PharmaCompass.
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