Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Moehs Iberica
03 1CJ Haide Biotech
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Fujian South Pharmaceutical
06 1Nippon Protein Co Ltd
07 1Nippon Rikagaku Yakuhin
08 1Waitaki Biosciences
01 1ACETYLCYSTEINE
02 1ACETYLCYSTEINE DRUG SUBSTANCE
03 1ACETYLCYSTEINE USP
04 1ACETYLCYSTEINE, USP
05 4N-ACETYL-L-CYSTEINE
01 2China
02 1Germany
03 1Italy
04 2Japan
05 1New Zealand
06 1Spain
01 6Active
02 2Inactive
01 3Complete
02 5Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
Status : Active
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-22
Pay. Date : 2013-01-07
DMF Number : 14304
Submission : 1999-07-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39018
Submission : 2023-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5091
Submission : 1983-07-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-18
Pay. Date : 2023-07-19
DMF Number : 37947
Submission : 2023-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7816
Submission : 1988-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21789
Submission : 2008-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3478
Submission : 1979-02-09
Status : Inactive
Type : II
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