Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
02 2Ajinomoto Company
03 1KANEKA AMERICA CORP
04 1Kyowa Hakko Bio
05 2Mitsubishi Tanabe Pharma
06 1Nippon Kayaku
07 1SIGMA TAU
01 7L-ALANINE
02 1L-ALANINE, L-METHIONINE & GLYCINE
03 1N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE (ALE)
01 1Germany
02 6Japan
03 2U.S.A
01 3Active
02 6Inactive
01 2Complete
02 7Blank
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 : 19769
Submission : 2006-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-30
Pay. Date : 2020-11-30
DMF Number : 31555
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29142
Submission : 2015-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6875
Submission : 1987-03-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2621
Submission : 1976-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10617
Submission : 1993-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1804
Submission : 1971-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4814
Submission : 1982-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3283
Submission : 1978-07-24
Status : Inactive
Type : II
A Alanine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alanine, including repackagers and relabelers. The FDA regulates Alanine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alanine 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 Alanine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alanine supplier is an individual or a company that provides Alanine active pharmaceutical ingredient (API) or Alanine finished formulations upon request. The Alanine suppliers may include Alanine API manufacturers, exporters, distributors and traders.
click here to find a list of Alanine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alanine DMF (Drug Master File) is a document detailing the whole manufacturing process of Alanine active pharmaceutical ingredient (API) in detail. Different forms of Alanine DMFs exist exist since differing nations have different regulations, such as Alanine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alanine DMF submitted to regulatory agencies in the US is known as a USDMF. Alanine USDMF includes data on Alanine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alanine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alanine suppliers with USDMF on PharmaCompass.
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