Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1LGM Pharma
03 1Shandong Chenghui Shuangda Pharmaceutical
04 1Cambrex Corporation
05 1Cerata Pharmaceuticals
06 1Dishman Carbogen Amcis
07 1Guangzhou Tosun Pharmaceutical
08 1Harman Finochem
09 1Ishita API
10 1Jiangsu Hengrui Medicine
11 1MSN Laboratories
12 1Siegfried AG
13 1Swati Spentose
01 1Brazil
02 3China
03 6India
04 1Switzerland
05 2U.S.A
01 6Active
02 7Blank
01 13Blank
01 13Blank
01 13Blank
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 : Reviewed
Rev. Date : 2020-08-06
Pay. Date : 2020-06-19
DMF Number : 34900
Submission : 2020-06-29
Status : Active
Type : II
NDC Package Code : 57884-0038
Start Marketing Date : 2020-06-29
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
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