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 1Aarti Drugs
04 1Apotex Pharmachem
05 1Aspen Biopharma Labs
06 1Aurobindo Pharma Limited
07 1Hengdian Group
08 1Hetero Drugs
09 1Hospira, Inc.
10 2KYORIN PHARMACEUTICAL CO LTD
11 1Lupin Ltd
12 1Sibbiotech
13 1Signa S.A. de C.V.
14 1TAPI Technology & API Services
15 1UQUIFA
16 1Unipex
17 1Viatris
18 2Zydus Lifesciences
01 1Canada
02 1China
03 1France
04 9India
05 1Israel
06 2Japan
07 1Mexico
08 1Russia
09 1Spain
10 2U.S.A
01 6Active
02 8Inactive
03 6Blank
01 20Blank
01 1218MF10335
02 19Blank
01 1WC-0017
02 1WC-0035a
03 1WC-0118
04 1WC-0128
05 1WC-0201
06 1WC-250
07 14Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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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
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-30
Pay. Date : 2013-04-12
DMF Number : 17013
Submission : 2003-12-10
Status : Active
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-826
Start Marketing Date : 2015-01-13
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 : 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 : 17002
Submission : 2003-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17092
Submission : 2004-01-12
Status : Inactive
Type : II
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 : 30999
Submission : 2016-12-27
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 :
Pay. Date :
DMF Number : 17110
Submission : 2004-01-21
Status : Inactive
Type : II
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