Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Asymchem Laboratories
03 1Dipharma
04 1Dipharma SA
05 1Honour Lab
06 1Innopharmax
07 1Maithri Drugs
08 1Shiratori Pharmaceutical
09 1Solara Active Pharma Sciences
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-18
Pay. Date : 2021-09-28
DMF Number : 36147
Submission : 2021-07-31
Status :
Type : II
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PharmaCompass offers a list of Sapropterin Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Sapropterin Hydrochloride API Price utilized in the formulation of products. Sapropterin Hydrochloride API Price is not always fixed or binding as the Sapropterin Hydrochloride Price is obtained through a variety of data sources. The Sapropterin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A kuvan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of kuvan, including repackagers and relabelers. The FDA regulates kuvan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. kuvan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A kuvan supplier is an individual or a company that provides kuvan active pharmaceutical ingredient (API) or kuvan finished formulations upon request. The kuvan suppliers may include kuvan API manufacturers, exporters, distributors and traders.
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A kuvan DMF (Drug Master File) is a document detailing the whole manufacturing process of kuvan active pharmaceutical ingredient (API) in detail. Different forms of kuvan DMFs exist exist since differing nations have different regulations, such as kuvan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A kuvan DMF submitted to regulatory agencies in the US is known as a USDMF. kuvan USDMF includes data on kuvan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The kuvan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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