DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1STARKS ASSOC INC
01 1LOMUSTINE (CCNU) BULK
02 1LOMUSTINE USP
01 1India
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-27
Pay. Date : 2021-04-15
DMF Number : 28405
Submission : 2014-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2420
Submission : 1975-03-11
Status : Active
Type : II
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PharmaCompass offers a list of Lomustine 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 Lomustine manufacturer or Lomustine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lomustine manufacturer or Lomustine supplier.
PharmaCompass also assists you with knowing the Lomustine API Price utilized in the formulation of products. Lomustine API Price is not always fixed or binding as the Lomustine Price is obtained through a variety of data sources. The Lomustine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lomustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomustine, including repackagers and relabelers. The FDA regulates Lomustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomustine 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 Lomustine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomustine supplier is an individual or a company that provides Lomustine active pharmaceutical ingredient (API) or Lomustine finished formulations upon request. The Lomustine suppliers may include Lomustine API manufacturers, exporters, distributors and traders.
click here to find a list of Lomustine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomustine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomustine active pharmaceutical ingredient (API) in detail. Different forms of Lomustine DMFs exist exist since differing nations have different regulations, such as Lomustine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomustine DMF submitted to regulatory agencies in the US is known as a USDMF. Lomustine USDMF includes data on Lomustine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomustine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lomustine suppliers with USDMF on PharmaCompass.
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