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Patent Expiration Date : 2026-01-07
US Patent Number : 7112592
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 206494
Patent Use Code : U-282
Delist Requested :
Patent Use Description : METHOD OF TREATING BAC...
Patent Expiration Date : 2026-01-07
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Exclusivity Code : NCE
Exclusivity Expiration Date : 2020-02-25
Application Number : 206494
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-01-26
Application Number : 206494
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2025-12-20
Application Number : 206494
Product Number : 1
Exclusivity Details :
Exclusivity Code : GAIN
Exclusivity Expiration Date : 2025-02-25
Application Number : 206494
Product Number : 1
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Avibactam Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avibactam Sodium, including repackagers and relabelers. The FDA regulates Avibactam Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avibactam 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 Avibactam Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avibactam Sodium supplier is an individual or a company that provides Avibactam Sodium active pharmaceutical ingredient (API) or Avibactam Sodium finished formulations upon request. The Avibactam Sodium suppliers may include Avibactam Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Avibactam Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avibactam Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Avibactam Sodium active pharmaceutical ingredient (API) in detail. Different forms of Avibactam Sodium DMFs exist exist since differing nations have different regulations, such as Avibactam Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avibactam Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Avibactam Sodium USDMF includes data on Avibactam Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avibactam Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avibactam Sodium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Avibactam Sodium Drug Master File in Korea (Avibactam Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Avibactam Sodium. The MFDS reviews the Avibactam Sodium KDMF as part of the drug registration process and uses the information provided in the Avibactam Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Avibactam Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Avibactam Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Avibactam Sodium suppliers with KDMF 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 Avibactam Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avibactam 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 Avibactam 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 Avibactam Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avibactam Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avibactam Sodium suppliers with NDC on PharmaCompass.
Avibactam 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 Avibactam 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 Avibactam Sodium GMP manufacturer or Avibactam Sodium GMP API supplier for your needs.
A Avibactam Sodium CoA (Certificate of Analysis) is a formal document that attests to Avibactam Sodium's compliance with Avibactam Sodium specifications and serves as a tool for batch-level quality control.
Avibactam Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Avibactam 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.
Avibactam Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Avibactam Sodium EP), Avibactam Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avibactam Sodium USP).
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