01 1FUKUZYU PHARMACEUTICAL CO LTD
01 1NPS-005
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26576
Submission : 2012-10-22
Status : Active
Type : II
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PharmaCompass offers a list of Fonadelpar API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Fonadelpar manufacturer or Fonadelpar supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fonadelpar manufacturer or Fonadelpar supplier.
A Fonadelpar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fonadelpar, including repackagers and relabelers. The FDA regulates Fonadelpar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fonadelpar API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fonadelpar supplier is an individual or a company that provides Fonadelpar active pharmaceutical ingredient (API) or Fonadelpar finished formulations upon request. The Fonadelpar suppliers may include Fonadelpar API manufacturers, exporters, distributors and traders.
click here to find a list of Fonadelpar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fonadelpar DMF (Drug Master File) is a document detailing the whole manufacturing process of Fonadelpar active pharmaceutical ingredient (API) in detail. Different forms of Fonadelpar DMFs exist exist since differing nations have different regulations, such as Fonadelpar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fonadelpar DMF submitted to regulatory agencies in the US is known as a USDMF. Fonadelpar USDMF includes data on Fonadelpar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fonadelpar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fonadelpar suppliers with USDMF on PharmaCompass.
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