Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Aspen API
03 1Dr. Reddy's Laboratories
04 1HRV Global Life Sciences
05 1Shanghai Minbiotech
06 1Aurobindo Pharma Limited
07 2BrightGene Bio-Medical Technology Co.,Ltd
08 1Eagle Chemical
09 1Formosa Laboratories
10 1GSK
11 1Guangzhou Tosun Pharmaceutical
12 2Hangzhou Zhongmei Huadong Pharmaceutical
13 1Jiangsu Hengrui Medicine
14 1Reliable Biopharmaceutical Corporation
15 1ScinoPharm Taiwan, Ltd
16 1Suzhou Biosyntech
17 1Viatris
18 1Wisdom Pharmaceutical
01 9China
02 1France
03 4India
04 1Netherlands
05 2Taiwan
06 2U.S.A
07 1United Kingdom
01 12Active
02 2Inactive
03 6Blank
01 20Blank
01 20Blank
01 1WC-0017
02 1WC-0034
03 18Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15259
Submission : 2001-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28762
Submission : 2014-11-30
Status : Active
Type : II
Registrant Name : Handok Co., Ltd.
Registration Date : 2013-03-29
Registration Number : 20130329-193-I-126-01
Manufacturer Name : Aspen notre dame de bondeville@Ajinomoto Omnichem@Aspen Oss BV@ORIL Industrie
Manufacturer Address : 1, rue de l'Abbaye, 76960 Notre Dame De Bondeville@Cooppallaan 91, Wetteren, Oost-Vlaanderen, B-9230, Belgium_x000D_ (Manufacturer 1)@Kloosterstraat6 5349 AB OSS, The Netherlands_x000D_ (Manufacturer 2)@13, rue Auguste Desgenétais, BOLBEC, 76210, France
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-04
Pay. Date : 2022-03-29
DMF Number : 22579
Submission : 2009-02-26
Status : Active
Type : II
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
NDC Package Code : 55111-839
Start Marketing Date : 2009-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-06
Pay. Date : 2016-09-06
DMF Number : 30767
Submission : 2016-07-15
Status : Active
Type : II
NDC Package Code : 62227-006
Start Marketing Date : 2019-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25093
Submission : 2011-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37499
Submission : 2022-10-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-05
Pay. Date : 2013-08-30
DMF Number : 27336
Submission : 2013-09-27
Status : Active
Type : II
NDC Package Code : 57884-0026
Start Marketing Date : 2013-09-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (180g/180g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-07
Pay. Date : 2013-09-26
DMF Number : 27563
Submission : 2013-12-30
Status : Active
Type : II
NDC Package Code : 65129-1258
Start Marketing Date : 2013-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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