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API SUPPLIERS
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38140
Submission : 2023-03-17
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36204
Submission : 2021-10-12
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sacubitril Sodium 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 Sacubitril Sodium manufacturer or Sacubitril Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sacubitril Sodium manufacturer or Sacubitril Sodium supplier.
PharmaCompass also assists you with knowing the Sacubitril Sodium API Price utilized in the formulation of products. Sacubitril Sodium API Price is not always fixed or binding as the Sacubitril Sodium Price is obtained through a variety of data sources. The Sacubitril Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sacubitril Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril Sodium, including repackagers and relabelers. The FDA regulates Sacubitril Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril Sodium 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 Sacubitril Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sacubitril Sodium supplier is an individual or a company that provides Sacubitril Sodium active pharmaceutical ingredient (API) or Sacubitril Sodium finished formulations upon request. The Sacubitril Sodium suppliers may include Sacubitril Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sacubitril Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril Sodium active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril Sodium DMFs exist exist since differing nations have different regulations, such as Sacubitril Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril Sodium USDMF includes data on Sacubitril Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril Sodium suppliers with USDMF on PharmaCompass.
A Sacubitril Sodium written confirmation (Sacubitril Sodium WC) is an official document issued by a regulatory agency to a Sacubitril Sodium manufacturer, verifying that the manufacturing facility of a Sacubitril Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sacubitril Sodium APIs or Sacubitril Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Sacubitril Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Sacubitril Sodium suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sacubitril Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sacubitril Sodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Sacubitril Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Sacubitril Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacubitril Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sacubitril Sodium suppliers with NDC on PharmaCompass.
Sacubitril Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Sacubitril Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sacubitril Sodium GMP manufacturer or Sacubitril Sodium GMP API supplier for your needs.
A Sacubitril Sodium CoA (Certificate of Analysis) is a formal document that attests to Sacubitril Sodium's compliance with Sacubitril Sodium specifications and serves as a tool for batch-level quality control.
Sacubitril Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Sacubitril Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Sacubitril Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacubitril Sodium EP), Sacubitril Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacubitril Sodium USP).
