Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 2Amoli Organics
03 1Amsa Spa
04 1Assertio Therapeutics
05 1Biesterfeld Spezialchemie GmbH
06 1COSMA S.p.A
07 2J.B.Chemicals & Pharmaceuticals
08 1Kreative Organics
09 1YUNG ZIP CHEMICAL INDUSTRIAL
01 1Brazil
02 1Germany
03 5India
04 2Italy
05 1Taiwan
06 1U.S.A
01 8Active
02 3Blank
01 11Blank
01 11Blank
01 1WC-0134
02 10Blank
Nortec Quimica is the largest API manufacturer in Latin America.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-11
Pay. Date : 2014-09-04
DMF Number : 15366
Submission : 2001-04-10
Status : Active
Type : II
NDC Package Code : 48589-0002
Start Marketing Date : 2009-11-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19020
Submission : 2006-01-04
Status : Active
Type : II
NDC Package Code : 48589-0002
Start Marketing Date : 2009-11-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27322
Submission : 2014-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23680
Submission : 2010-03-21
Status : Active
Type : II
Date of Issue : 2016-06-23
Valid Till : 2019-07-02
Written Confirmation Number : WC-0134
Address of the Firm :
NDC Package Code : 62512-0051
Start Marketing Date : 2015-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-12
Pay. Date : 2014-05-19
DMF Number : 28208
Submission : 2014-04-18
Status : Active
Type : II
NDC Package Code : 62512-0051
Start Marketing Date : 2015-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26224
Submission : 2012-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14831
Submission : 2000-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25107
Submission : 2011-06-30
Status : Active
Type : II
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