DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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01 1Dr. Reddy's Laboratories
02 2Eli Lilly
03 1Olon S.p.A
04 1Solara Active Pharma Sciences
05 1Wockhardt
06 1Blank
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01 2BULK PRODUCTION OF NIZATIDINE
02 2NIZATIDINE
03 3NIZATIDINE USP
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01 3India
02 1Italy
03 2U.S.A
04 1Blank
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01 2Active
02 5Inactive
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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
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PharmaCompass offers a list of Nizatidine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nizatidine manufacturer or Nizatidine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nizatidine manufacturer or Nizatidine supplier.
PharmaCompass also assists you with knowing the Nizatidine API Price utilized in the formulation of products. Nizatidine API Price is not always fixed or binding as the Nizatidine Price is obtained through a variety of data sources. The Nizatidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Axid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Axid, including repackagers and relabelers. The FDA regulates Axid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Axid 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 Axid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Axid supplier is an individual or a company that provides Axid active pharmaceutical ingredient (API) or Axid finished formulations upon request. The Axid suppliers may include Axid API manufacturers, exporters, distributors and traders.
click here to find a list of Axid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Axid DMF (Drug Master File) is a document detailing the whole manufacturing process of Axid active pharmaceutical ingredient (API) in detail. Different forms of Axid DMFs exist exist since differing nations have different regulations, such as Axid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Axid DMF submitted to regulatory agencies in the US is known as a USDMF. Axid USDMF includes data on Axid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Axid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Axid suppliers with USDMF on PharmaCompass.
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