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 3Jost Chemical
05 1Merck Group
06 1Raks Pharma
07 4S 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 : 2023-09-26
Pay. Date : 2023-08-24
DMF Number : 37750
Submission : 2022-12-29
Status :
Type : II
A Potassium phosphate (dibasic) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium phosphate (dibasic), including repackagers and relabelers. The FDA regulates Potassium phosphate (dibasic) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium phosphate (dibasic) 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 (dibasic) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium phosphate (dibasic) supplier is an individual or a company that provides Potassium phosphate (dibasic) active pharmaceutical ingredient (API) or Potassium phosphate (dibasic) finished formulations upon request. The Potassium phosphate (dibasic) suppliers may include Potassium phosphate (dibasic) API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium phosphate (dibasic) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium phosphate (dibasic) DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium phosphate (dibasic) active pharmaceutical ingredient (API) in detail. Different forms of Potassium phosphate (dibasic) DMFs exist exist since differing nations have different regulations, such as Potassium phosphate (dibasic) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium phosphate (dibasic) DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium phosphate (dibasic) USDMF includes data on Potassium phosphate (dibasic)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium phosphate (dibasic) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium phosphate (dibasic) suppliers with USDMF on PharmaCompass.
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