Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Seqens
03 1Supriya Lifescience
04 1Alkem Laboratories
05 1Arevipharma
06 1Maithri Drugs
01 5ESKETAMINE HYDROCHLORIDE
02 1S-KETAMINE HYDROCHLORIDE
01 1Brazil
02 1France
03 1Germany
04 3India
01 6Active
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-22
Pay. Date : 2023-01-31
DMF Number : 37647
Submission : 2022-12-09
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16737
Submission : 2003-07-31
Status : Active
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36426
Submission : 2021-11-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-10-14
DMF Number : 37461
Submission : 2022-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-30
Pay. Date : 2022-12-01
DMF Number : 36990
Submission : 2022-11-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37012
Submission : 2022-08-04
Status : Active
Type : II
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