01 1Gilead Sciences
01 1LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16237
Submission : 2002-11-06
Status : Inactive
Type : II
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PharmaCompass offers a list of Lurtotecan 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 Lurtotecan manufacturer or Lurtotecan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lurtotecan manufacturer or Lurtotecan supplier.
PharmaCompass also assists you with knowing the Lurtotecan API Price utilized in the formulation of products. Lurtotecan API Price is not always fixed or binding as the Lurtotecan Price is obtained through a variety of data sources. The Lurtotecan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lurtotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurtotecan, including repackagers and relabelers. The FDA regulates Lurtotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurtotecan 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 Lurtotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurtotecan supplier is an individual or a company that provides Lurtotecan active pharmaceutical ingredient (API) or Lurtotecan finished formulations upon request. The Lurtotecan suppliers may include Lurtotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Lurtotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lurtotecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurtotecan active pharmaceutical ingredient (API) in detail. Different forms of Lurtotecan DMFs exist exist since differing nations have different regulations, such as Lurtotecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurtotecan DMF submitted to regulatory agencies in the US is known as a USDMF. Lurtotecan USDMF includes data on Lurtotecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurtotecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurtotecan suppliers with USDMF on PharmaCompass.
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