Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Abbott Laboratories
03 1Amphastar Pharmaceuticals
04 1Apothecon Pharmaceuticals
05 1Emcure Pharmaceuticals
06 2Enaltec Labs Private Limited
07 1G&A Assoicates, LLC
08 1MSN Laboratories
09 1Merck Serono
10 1NISSHIN PHARMA INC
11 1Royal DSM
12 1Sunny Pharmtech
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26447
Submission : 2012-09-26
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-17
Pay. Date : 2014-05-12
DMF Number : 27805
Submission : 2013-12-28
Status :
Type : II
A Vitamin K1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin K1, including repackagers and relabelers. The FDA regulates Vitamin K1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin K1 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 Vitamin K1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin K1 supplier is an individual or a company that provides Vitamin K1 active pharmaceutical ingredient (API) or Vitamin K1 finished formulations upon request. The Vitamin K1 suppliers may include Vitamin K1 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin K1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin K1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin K1 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin K1 DMFs exist exist since differing nations have different regulations, such as Vitamin K1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin K1 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin K1 USDMF includes data on Vitamin K1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin K1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin K1 suppliers with USDMF on PharmaCompass.
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