Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1LGM Pharma
03 1Moehs Iberica
04 1Shandong Chenghui Shuangda Pharmaceutical
05 1Cambrex Corporation
06 1Cerata Pharmaceuticals
07 1Dishman Carbogen Amcis
08 1Guangzhou Tosun Pharmaceutical
09 1Harman Finochem
10 1Ishita API
11 1Jiangsu Hengrui Medicine
12 1MSN Laboratories
13 1Siegfried AG
14 1Swati Spentose
01 1Brazil
02 3China
03 6India
04 1Spain
05 1Switzerland
06 2U.S.A
01 6Active
02 8Blank
01 14Blank
01 14Blank
01 14Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-25
Pay. Date : 2018-11-13
DMF Number : 33285
Submission : 2018-11-21
Status : Active
Type : II
NDC Package Code : 59014-0053
Start Marketing Date : 2018-04-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35322
Submission : 2020-10-31
Status : Active
Type : II
NDC Package Code : 72640-017
Start Marketing Date : 2020-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-13
Pay. Date : 2018-03-09
DMF Number : 32369
Submission : 2017-12-22
Status : Active
Type : II
NDC Package Code : 61876-0727
Start Marketing Date : 2017-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-01-13
Registration Number : 20210113-210-J-819
Manufacturer Name : Dishman Carbogen Amcis Limited
Manufacturer Address : Survey no. 47&48, paiki sub plot no. 1, Village : Lodariyal, Taluka: Sanand, District : Ahmedabad-382 220, Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 11938
Submission : 1996-04-18
Status : Active
Type : II
NDC Package Code : 17381-024
Start Marketing Date : 2010-04-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-05
Pay. Date : 2015-09-29
DMF Number : 19177
Submission : 2006-02-10
Status : Active
Type : II
NDC Package Code : 12651-116
Start Marketing Date : 2011-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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