DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Hetero Drugs
06 1Hospira, Inc.
07 2KYORIN PHARMACEUTICAL CO LTD
08 1Lupin Ltd
09 1Signa S.A. de C.V.
10 1UQUIFA
11 1Viatris
12 2Zydus Lifesciences
01 4GATIFLOXACIN
02 2GATIFLOXACIN ANHYDROUS
03 1GATIFLOXACIN DRUG SUBSTANCE
04 4GATIFLOXACIN HEMIHYDRATE
05 1GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE)
06 1GATIFLOXACIN SESQUIHYDRATE
07 1TEQUIN I.V. (GATIFLOXACIN)
01 1Canada
02 6India
03 1Israel
04 2Japan
05 1Mexico
06 1Spain
07 2U.S.A
01 6Active
02 8Inactive
01 3Complete
02 11Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 17012
Submission : 2003-12-02
Status : Active
Type : II
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 : 20685
Submission : 2007-07-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-09-03
DMF Number : 26452
Submission : 2012-09-27
Status : Active
Type : II
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 : 15597
Submission : 2001-08-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13902
Submission : 1998-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23552
Submission : 2010-04-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-30
Pay. Date : 2013-04-12
DMF Number : 17013
Submission : 2003-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17002
Submission : 2003-12-03
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.
A Gatifloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gatifloxacin active pharmaceutical ingredient (API) in detail. Different forms of Gatifloxacin DMFs exist exist since differing nations have different regulations, such as Gatifloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gatifloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Gatifloxacin USDMF includes data on Gatifloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gatifloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gatifloxacin suppliers with USDMF on PharmaCompass.
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