Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Avantor Performance Materials
03 1Extrovis AG
04 1Global Calcium
05 1India Phosphate
06 1Jost Chemical
07 1Raks Pharma
08 1Rotem Industries
09 2S D Fine Chem Limited
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-02
Pay. Date : 2023-08-25
DMF Number : 37752
Submission : 2022-12-23
Status :
Type : II
A Potassium Dihydrogen Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Dihydrogen Phosphate, including repackagers and relabelers. The FDA regulates Potassium Dihydrogen Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Dihydrogen 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 Potassium Dihydrogen Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Dihydrogen Phosphate supplier is an individual or a company that provides Potassium Dihydrogen Phosphate active pharmaceutical ingredient (API) or Potassium Dihydrogen Phosphate finished formulations upon request. The Potassium Dihydrogen Phosphate suppliers may include Potassium Dihydrogen Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Dihydrogen Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Dihydrogen Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Dihydrogen Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Dihydrogen Phosphate DMFs exist exist since differing nations have different regulations, such as Potassium Dihydrogen Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Dihydrogen Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Dihydrogen Phosphate USDMF includes data on Potassium Dihydrogen Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Dihydrogen Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Dihydrogen Phosphate suppliers with USDMF on PharmaCompass.
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