01 1Atul Bioscience Ltd
01 1N-(BENZYLOXYCARBONYL)-L-VALINE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32446
Submission : 2018-01-24
Status : Active
Type : II
A Z-Valine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Z-Valine, including repackagers and relabelers. The FDA regulates Z-Valine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Z-Valine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Z-Valine supplier is an individual or a company that provides Z-Valine active pharmaceutical ingredient (API) or Z-Valine finished formulations upon request. The Z-Valine suppliers may include Z-Valine API manufacturers, exporters, distributors and traders.
click here to find a list of Z-Valine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Z-Valine DMF (Drug Master File) is a document detailing the whole manufacturing process of Z-Valine active pharmaceutical ingredient (API) in detail. Different forms of Z-Valine DMFs exist exist since differing nations have different regulations, such as Z-Valine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Z-Valine DMF submitted to regulatory agencies in the US is known as a USDMF. Z-Valine USDMF includes data on Z-Valine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Z-Valine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Z-Valine suppliers with USDMF on PharmaCompass.
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