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 2TAPI Technology & API Services
04 1AASraw Biochemical Technology Co., Ltd
05 1Aarti Drugs
06 1Apotex Pharmachem
07 1Aspire Lifesciences Pvt Ltd
08 2Aurobindo Pharma Limited
09 1Aurore Life Sciences
10 1Cadila Pharmaceuticals
11 1Cambrex Corporation
12 2Cipla
13 1Erregierre SpA
14 2Glochem Industries
15 1Guangzhou Tosun Pharmaceutical
16 1Hanmi Pharmaceutical
17 1Hetero Drugs
18 1Jeil Pharmaceutical Co., Ltd
19 1Kyongbo Pharmaceutical Co., Ltd
20 1Medilux Laboratories
21 1Olon S.p.A
22 1Raks Pharma
23 1Sai Tech Pharmaceuticals Pvt Ltd
24 1Shodhana Laboratories Pvt. Ltd
25 1Sichuan Xieli Pharmaceutical
26 1Srini Pharmaceuticals
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-0219
09 1WC-0422
10 23Blank
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 : 21327
Submission : 2008-02-11
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-29
Pay. Date : 2014-02-24
DMF Number : 27969
Submission : 2014-03-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-09-11
DMF Number : 27064
Submission : 2013-05-06
Status : Active
Type : II
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
NDC Package Code : 65691-0079
Start Marketing Date : 2013-05-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
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 : Reviewed
Rev. Date : 2016-10-07
Pay. Date : 2015-09-22
DMF Number : 29721
Submission : 2015-09-24
Status : Active
Type : II
Certificate Number : R1-CEP 2015-171 - Rev 00
Issue Date : 2022-04-08
Type : Chemical
Substance Number : 2375
Status : Valid
Registration Number : 303MF10064
Registrant's Address : Strada Rivoltana Km. 6/7 20053 Rodano (MI), Italy
Initial Date of Registration : 2021-04-13
Latest Date of Registration : --
NDC Package Code : 17337-0071
Start Marketing Date : 2019-08-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 39175
Submission : 2023-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26492
Submission : 2012-09-27
Status : Inactive
Type : II
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