01 1Sutro Biopharma
01 1TRNA AND AMINOACYL TRNA SYNTHETASE REAGENTS
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31931
Submission : 2017-10-02
Status : Active
Type : II
A Aminoacyl tRNA synthetase-IN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminoacyl tRNA synthetase-IN-1, including repackagers and relabelers. The FDA regulates Aminoacyl tRNA synthetase-IN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminoacyl tRNA synthetase-IN-1 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 Aminoacyl tRNA synthetase-IN-1 supplier is an individual or a company that provides Aminoacyl tRNA synthetase-IN-1 active pharmaceutical ingredient (API) or Aminoacyl tRNA synthetase-IN-1 finished formulations upon request. The Aminoacyl tRNA synthetase-IN-1 suppliers may include Aminoacyl tRNA synthetase-IN-1 API manufacturers, exporters, distributors and traders.
click here to find a list of Aminoacyl tRNA synthetase-IN-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aminoacyl tRNA synthetase-IN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Aminoacyl tRNA synthetase-IN-1 active pharmaceutical ingredient (API) in detail. Different forms of Aminoacyl tRNA synthetase-IN-1 DMFs exist exist since differing nations have different regulations, such as Aminoacyl tRNA synthetase-IN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aminoacyl tRNA synthetase-IN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. Aminoacyl tRNA synthetase-IN-1 USDMF includes data on Aminoacyl tRNA synthetase-IN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aminoacyl tRNA synthetase-IN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aminoacyl tRNA synthetase-IN-1 suppliers with USDMF on PharmaCompass.
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