01 1Raks Pharma
01 1POTASSIUM DOBESILATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2015-12-18
DMF Number : 30083
Submission : 2016-02-25
Status : Active
Type : II
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PharmaCompass offers a list of Potassium Dobesilate 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 Potassium Dobesilate manufacturer or Potassium Dobesilate supplier for your needs.
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A Potassium Dobesilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Dobesilate, including repackagers and relabelers. The FDA regulates Potassium Dobesilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Dobesilate 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 Potassium Dobesilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Potassium Dobesilate supplier is an individual or a company that provides Potassium Dobesilate active pharmaceutical ingredient (API) or Potassium Dobesilate finished formulations upon request. The Potassium Dobesilate suppliers may include Potassium Dobesilate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Dobesilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Potassium Dobesilate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Dobesilate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Dobesilate DMFs exist exist since differing nations have different regulations, such as Potassium Dobesilate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Dobesilate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Dobesilate USDMF includes data on Potassium Dobesilate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Dobesilate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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