01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
01 1DPA-713 I 124 INJECTION
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27301
Submission : 2013-10-01
Status : Active
Type : II
A Dpa Choline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dpa Choline, including repackagers and relabelers. The FDA regulates Dpa Choline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dpa Choline 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 Dpa Choline supplier is an individual or a company that provides Dpa Choline active pharmaceutical ingredient (API) or Dpa Choline finished formulations upon request. The Dpa Choline suppliers may include Dpa Choline API manufacturers, exporters, distributors and traders.
click here to find a list of Dpa Choline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dpa Choline DMF (Drug Master File) is a document detailing the whole manufacturing process of Dpa Choline active pharmaceutical ingredient (API) in detail. Different forms of Dpa Choline DMFs exist exist since differing nations have different regulations, such as Dpa Choline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dpa Choline DMF submitted to regulatory agencies in the US is known as a USDMF. Dpa Choline USDMF includes data on Dpa Choline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dpa Choline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dpa Choline suppliers with USDMF on PharmaCompass.
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