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