DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1HRV Global Life Sciences
03 1AASraw Biochemical Technology Co., Ltd
04 1Aarti Drugs
05 1Apotex Pharmachem
06 1Aspire Lifesciences Pvt Ltd
07 2Aurobindo Pharma Limited
08 1Aurore Life Sciences
09 1Cadila Pharmaceuticals
10 1Cambrex Corporation
11 2Cipla
12 1Erregierre SpA
13 2Glochem Industries
14 1Guangzhou Tosun Pharmaceutical
15 1Hanmi Pharmaceutical
16 1Hetero Drugs
17 1Jeil Pharmaceutical Co., Ltd
18 1Kyongbo Pharmaceutical Co., Ltd
19 1Medilux Laboratories
20 1Olon S.p.A
21 1Raks Pharma
22 1Sai Tech Pharmaceuticals Pvt Ltd
23 1Shodhana Laboratories Pvt. Ltd
24 1Sichuan Xieli Pharmaceutical
25 1Srini Pharmaceuticals
26 2TAPI Technology & API Services
27 1Teva Pharmaceutical Industries
28 1Waterstone Pharmaceuticals Inc.
01 1Canada
02 4China
03 18India
04 3Israel
05 2Italy
06 3South Korea
07 1U.S.A
01 13Active
02 5Inactive
03 14Blank
01 10Valid
02 1Withdrawn by Holder
03 21Blank
01 1226MF10007
02 1227MF10039
03 1227MF10048
04 1227MF10053
05 1228MF10113
06 1303MF10064
07 26Blank
01 1WC-0023
02 1WC-0029
03 1WC-0034
04 1WC-0066
05 1WC-0074
06 1WC-0119
07 1WC-0128
08 1WC-0422
09 24Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-02
Pay. Date : 2013-03-22
DMF Number : 16143
Submission : 2002-09-23
Status : Active
Type : II
Certificate Number : R1-CEP 2014-054 - Rev 01
Issue Date : 2023-03-31
Type : Chemical
Substance Number : 2375
Status : Valid
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2020-09-17
Registration Number : 20200917-209-J-745
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21650
Submission : 2008-05-22
Status : Active
Type : II
NDC Package Code : 62704-0115
Start Marketing Date : 1998-01-01
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 : 2015-09-25
DMF Number : 15932
Submission : 2002-04-10
Status : Active
Type : II
Certificate Number : R1-CEP 2010-205 - Rev 00
Issue Date : 2017-09-06
Type : Chemical
Substance Number : 2375
Status : Valid
Registration Number : 226MF10007
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2014-01-08
Latest Date of Registration : --
NDC Package Code : 49706-1723
Start Marketing Date : 2010-01-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39175
Submission : 2023-11-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-04
Pay. Date : 2013-09-05
DMF Number : 21682
Submission : 2008-06-05
Status : Active
Type : II
Certificate Number : CEP 2023-123 - Rev 00
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 2375
Status : Valid
Date of Issue : 2013-06-11
Valid Till : 2016-06-05
Written Confirmation Number : WC-0029
Address of the Firm :
NDC Package Code : 24234-0008
Start Marketing Date : 2023-11-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-14
Pay. Date : 2017-08-01
DMF Number : 31952
Submission : 2017-08-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36445
Submission : 2021-10-23
Status : Active
Type : II
Certificate Number : CEP 2022-165 - Rev 00
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2375
Status : Valid
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-12
Pay. Date : 2018-05-25
DMF Number : 25281
Submission : 2011-09-06
Status : Active
Type : II
Certificate Number : R1-CEP 2011-349 - Rev 00
Issue Date : 2020-11-30
Type : Chemical
Substance Number : 2375
Status : Valid
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
NDC Package Code : 65977-0065
Start Marketing Date : 1997-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2021-10-14
Registration Number : 20211014-209-J-1021
Manufacturer Name : Hetero Drugs Limited(Unit-IX)
Manufacturer Address : Plot No.1, Hetero Infrastructure-SEZ Ltd, N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531 081, Andhra Pradesh, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26492
Submission : 2012-09-27
Status : Inactive
Type : II
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