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
19 1Blank
01 1Canada
02 1China
03 1France
04 9India
05 1Israel
06 2Japan
07 1Mexico
08 1Russia
09 1Spain
10 2U.S.A
11 1Blank
01 7Active
02 8Inactive
03 6Blank
01 21Blank
01 1218MF10335
02 20Blank
01 1WC-0017
02 1WC-0035a
03 1WC-0118
04 1WC-0128
05 1WC-0201
06 1WC-250
07 15Blank
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 |
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 : Reviewed
Rev. Date : 2013-11-14
Pay. Date : 2013-09-03
DMF Number : 26452
Submission : 2012-09-27
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-792
Start Marketing Date : 2023-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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 : 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 : 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 : 20685
Submission : 2007-07-13
Status : Active
Type : II
Date of Issue : 2014-03-06
Valid Till : 2016-07-02
Written Confirmation Number : WC-0128
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40752
Submission : 2024-11-14
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13905
Submission : 1998-12-21
Status : Inactive
Type : II
Date of Issue : 2019-10-01
Valid Till : 2022-07-02
Written Confirmation Number : WC-250
Address of the Firm :
A gatifloxacin anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gatifloxacin anhydrous, including repackagers and relabelers. The FDA regulates gatifloxacin anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gatifloxacin anhydrous 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 anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gatifloxacin anhydrous supplier is an individual or a company that provides gatifloxacin anhydrous active pharmaceutical ingredient (API) or gatifloxacin anhydrous finished formulations upon request. The gatifloxacin anhydrous suppliers may include gatifloxacin anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of gatifloxacin anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 18 companies offering gatifloxacin anhydrous
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