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 1TAPI Technology & API Services
04 1Aarti Drugs
05 1Apotex Pharmachem
06 1Aspen Biopharma Labs
07 1Aurobindo Pharma Limited
08 1Hengdian Group
09 1Hetero Drugs
10 1Hospira, Inc.
11 2KYORIN PHARMACEUTICAL CO LTD
12 1Lupin Ltd
13 1Sibbiotech
14 1Signa S.A. de C.V.
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.
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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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 : 23552
Submission : 2010-04-08
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
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 : 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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 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 : 13905
Submission : 1998-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30999
Submission : 2016-12-27
Status : Inactive
Type : II
A Gatifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gatifloxacin, including repackagers and relabelers. The FDA regulates Gatifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gatifloxacin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Gatifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gatifloxacin supplier is an individual or a company that provides Gatifloxacin active pharmaceutical ingredient (API) or Gatifloxacin finished formulations upon request. The Gatifloxacin suppliers may include Gatifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Gatifloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 18 companies offering Gatifloxacin
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