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 (L)-PROLINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-PROLINE, including repackagers and relabelers. The FDA regulates (L)-PROLINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-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 (L)-PROLINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (L)-PROLINE supplier is an individual or a company that provides (L)-PROLINE active pharmaceutical ingredient (API) or (L)-PROLINE finished formulations upon request. The (L)-PROLINE suppliers may include (L)-PROLINE API manufacturers, exporters, distributors and traders.
click here to find a list of (L)-PROLINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (L)-PROLINE DMF (Drug Master File) is a document detailing the whole manufacturing process of (L)-PROLINE active pharmaceutical ingredient (API) in detail. Different forms of (L)-PROLINE DMFs exist exist since differing nations have different regulations, such as (L)-PROLINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (L)-PROLINE DMF submitted to regulatory agencies in the US is known as a USDMF. (L)-PROLINE USDMF includes data on (L)-PROLINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (L)-PROLINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (L)-PROLINE suppliers with USDMF on PharmaCompass.
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