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