Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 2Ajinomoto Company
03 1Avanti Polar Lipids
04 1Mitsubishi Tanabe Pharma
05 1SIGMA TAU
01 11,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHO-L-SERINE(SODIUM SALT) (DOPS)
02 1L - SERINE
03 2L-SERINE
04 1L-SERINE (PROCESS II)
05 1L-SERINE - (S 4500 FD
01 1Germany
02 3Japan
03 2U.S.A
01 3Active
02 3Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37552
Submission : 2022-10-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31568
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-09
Pay. Date : 2021-05-05
DMF Number : 31559
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15668
Submission : 2001-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1806
Submission : 1971-09-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6260
Submission : 1986-04-04
Status : Inactive
Type : II
A (L)-SERINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (L)-SERINE, including repackagers and relabelers. The FDA regulates (L)-SERINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (L)-SERINE 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)-SERINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (L)-SERINE supplier is an individual or a company that provides (L)-SERINE active pharmaceutical ingredient (API) or (L)-SERINE finished formulations upon request. The (L)-SERINE suppliers may include (L)-SERINE API manufacturers, exporters, distributors and traders.
click here to find a list of (L)-SERINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (L)-SERINE DMF (Drug Master File) is a document detailing the whole manufacturing process of (L)-SERINE active pharmaceutical ingredient (API) in detail. Different forms of (L)-SERINE DMFs exist exist since differing nations have different regulations, such as (L)-SERINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (L)-SERINE DMF submitted to regulatory agencies in the US is known as a USDMF. (L)-SERINE USDMF includes data on (L)-SERINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (L)-SERINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (L)-SERINE suppliers with USDMF on PharmaCompass.
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