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