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 1Sigmak Lifesciences
04 1Aarti Drugs
05 1Apotex Pharmachem
06 1Aspen Biopharma Labs
07 1Aurobindo Pharma Limited
08 1Hengdian Group
09 1Hetero Drugs
10 1Hospira, Inc.
11 2Iharanikkei Chemical Industry
12 2KYORIN PHARMACEUTICAL CO LTD
13 1Lupin Ltd
14 1Sibbiotech
15 1Signa S.A. de C.V.
16 1Teva API
17 1UQUIFA
18 1Unipex
19 1Viatris
20 2Zydus Lifesciences
01 1Canada
02 1China
03 1France
04 10India
05 1Israel
06 4Japan
07 1Mexico
08 1Russia
09 1Spain
10 2U.S.A
01 6Active
02 10Inactive
03 7Blank
01 23Blank
01 1218MF10335
02 22Blank
01 1WC-0017
02 1WC-0035a
03 1WC-0118
04 1WC-0128
05 1WC-0201
06 1WC-250
07 17Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 17012
Submission : 2003-12-02
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-040
Start Marketing Date : 2011-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15597
Submission : 2001-08-27
Status : Active
Type : II
NDC Package Code : 53476-1155
Start Marketing Date : 2018-07-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Handok Co., Ltd.
Registration Date : 2013-05-07
Registration Number : 20130507-174-I-282-01
Manufacturer Name : Kyorin Pharmaceutical Group Facilities Co., Ltd. Noshiro Plant
Manufacturer Address : 1, Matsubara, Noshiro-shi, Akita, 016-0000, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17822
Submission : 2004-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16965
Submission : 2003-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13902
Submission : 1998-12-18
Status : Inactive
Type : II
Registration Number : 218MF10335
Registrant's Address : 6 Kanda Surugadai 4-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : --
NDC Package Code : 53476-1155
Start Marketing Date : 2018-07-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Handok Co., Ltd.
Registration Date : 2013-05-07
Registration Number : 20130507-174-I-282-01
Manufacturer Name : Kyorin Pharmaceutical Group Facilities Co., Ltd. Noshiro Plant
Manufacturer Address : 1, Matsubara, Noshiro-shi, Akita, 016-0000, Japan
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15599
Submission : 2001-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17462
Submission : 2004-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30999
Submission : 2016-12-27
Status : Inactive
Type : II
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