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01 1MSN Laboratories
02 1Teva Pharmaceutical Industries
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01 2SAMIDORPHAN L-MALATE
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01 1India
02 1Israel
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01 2Active
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01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-27
Pay. Date : 2025-01-13
DMF Number : 41151
Submission : 2024-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-02-04
Pay. Date : 2024-11-21
DMF Number : 40848
Submission : 2024-12-19
Status : Active
Type : II
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PharmaCompass offers a list of Samidorphan L-Malate 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 Samidorphan L-Malate manufacturer or Samidorphan L-Malate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Samidorphan L-Malate manufacturer or Samidorphan L-Malate supplier.
PharmaCompass also assists you with knowing the Samidorphan L-Malate API Price utilized in the formulation of products. Samidorphan L-Malate API Price is not always fixed or binding as the Samidorphan L-Malate Price is obtained through a variety of data sources. The Samidorphan L-Malate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Samidorphan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Samidorphan, including repackagers and relabelers. The FDA regulates Samidorphan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Samidorphan 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 Samidorphan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Samidorphan supplier is an individual or a company that provides Samidorphan active pharmaceutical ingredient (API) or Samidorphan finished formulations upon request. The Samidorphan suppliers may include Samidorphan API manufacturers, exporters, distributors and traders.
click here to find a list of Samidorphan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Samidorphan DMF (Drug Master File) is a document detailing the whole manufacturing process of Samidorphan active pharmaceutical ingredient (API) in detail. Different forms of Samidorphan DMFs exist exist since differing nations have different regulations, such as Samidorphan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Samidorphan DMF submitted to regulatory agencies in the US is known as a USDMF. Samidorphan USDMF includes data on Samidorphan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Samidorphan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Samidorphan suppliers with USDMF on PharmaCompass.
We have 2 companies offering Samidorphan
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