DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 2Eli Lilly
03 1Olon S.p.A
04 1Solara Active Pharma Sciences
05 1Wockhardt
06 1Blank
01 2BULK PRODUCTION OF NIZATIDINE
02 2NIZATIDINE
03 3NIZATIDINE USP
01 3India
02 1Italy
03 2U.S.A
04 1Blank
01 2Active
02 5Inactive
01 1Complete
02 6Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-23
DMF Number : 14036
Submission : 1999-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6034
Submission : 1985-09-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6029
Submission : 1985-09-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18545
Submission : 2005-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13192
Submission : 1998-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14710
Submission : 2000-02-10
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14101
Submission : 1999-04-30
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Nizatidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nizatidine, including repackagers and relabelers. The FDA regulates Nizatidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nizatidine 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 Nizatidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nizatidine supplier is an individual or a company that provides Nizatidine active pharmaceutical ingredient (API) or Nizatidine finished formulations upon request. The Nizatidine suppliers may include Nizatidine API manufacturers, exporters, distributors and traders.
click here to find a list of Nizatidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nizatidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nizatidine active pharmaceutical ingredient (API) in detail. Different forms of Nizatidine DMFs exist exist since differing nations have different regulations, such as Nizatidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nizatidine DMF submitted to regulatory agencies in the US is known as a USDMF. Nizatidine USDMF includes data on Nizatidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nizatidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nizatidine suppliers with USDMF on PharmaCompass.
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