Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 1Ajinomoto Company
03 1Mitsubishi Tanabe Pharma
04 1SIGMA TAU
05 1Blank
01 5L-PROLINE
01 1Germany
02 2Japan
03 1U.S.A
04 1Blank
01 2Active
02 3Inactive
01 1Complete
02 4Blank
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26400
Submission : 2012-09-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31557
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10063
Submission : 1993-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3668
Submission : 1979-12-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1805
Submission : 1971-09-24
Status : Inactive
Type : II
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A Proline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proline, including repackagers and relabelers. The FDA regulates Proline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proline 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 Proline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Proline supplier is an individual or a company that provides Proline active pharmaceutical ingredient (API) or Proline finished formulations upon request. The Proline suppliers may include Proline API manufacturers, exporters, distributors and traders.
click here to find a list of Proline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Proline DMF (Drug Master File) is a document detailing the whole manufacturing process of Proline active pharmaceutical ingredient (API) in detail. Different forms of Proline DMFs exist exist since differing nations have different regulations, such as Proline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proline DMF submitted to regulatory agencies in the US is known as a USDMF. Proline USDMF includes data on Proline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proline suppliers with USDMF on PharmaCompass.
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