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ABOUT THIS PAGE
A Norepinephrine Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norepinephrine Bitartrate, including repackagers and relabelers. The FDA regulates Norepinephrine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norepinephrine Bitartrate 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 Norepinephrine Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norepinephrine Bitartrate supplier is an individual or a company that provides Norepinephrine Bitartrate active pharmaceutical ingredient (API) or Norepinephrine Bitartrate finished formulations upon request. The Norepinephrine Bitartrate suppliers may include Norepinephrine Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Norepinephrine Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norepinephrine Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Norepinephrine Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Norepinephrine Bitartrate DMFs exist exist since differing nations have different regulations, such as Norepinephrine Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norepinephrine Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Norepinephrine Bitartrate USDMF includes data on Norepinephrine Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norepinephrine Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norepinephrine Bitartrate 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 Norepinephrine Bitartrate Drug Master File in Korea (Norepinephrine Bitartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Norepinephrine Bitartrate. The MFDS reviews the Norepinephrine Bitartrate KDMF as part of the drug registration process and uses the information provided in the Norepinephrine Bitartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Norepinephrine Bitartrate 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 Norepinephrine Bitartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Norepinephrine Bitartrate suppliers with KDMF on PharmaCompass.
A Norepinephrine Bitartrate CEP of the European Pharmacopoeia monograph is often referred to as a Norepinephrine Bitartrate Certificate of Suitability (COS). The purpose of a Norepinephrine Bitartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norepinephrine Bitartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norepinephrine Bitartrate to their clients by showing that a Norepinephrine Bitartrate CEP has been issued for it. The manufacturer submits a Norepinephrine Bitartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norepinephrine Bitartrate CEP holder for the record. Additionally, the data presented in the Norepinephrine Bitartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norepinephrine Bitartrate DMF.
A Norepinephrine Bitartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norepinephrine Bitartrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Norepinephrine Bitartrate suppliers with CEP (COS) on PharmaCompass.
A Norepinephrine Bitartrate written confirmation (Norepinephrine Bitartrate WC) is an official document issued by a regulatory agency to a Norepinephrine Bitartrate manufacturer, verifying that the manufacturing facility of a Norepinephrine Bitartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Norepinephrine Bitartrate APIs or Norepinephrine Bitartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Norepinephrine Bitartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Norepinephrine Bitartrate 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 Norepinephrine Bitartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Norepinephrine Bitartrate 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 Norepinephrine Bitartrate 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 Norepinephrine Bitartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Norepinephrine Bitartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Norepinephrine Bitartrate suppliers with NDC on PharmaCompass.
Norepinephrine Bitartrate 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 Norepinephrine Bitartrate 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 Norepinephrine Bitartrate GMP manufacturer or Norepinephrine Bitartrate GMP API supplier for your needs.
A Norepinephrine Bitartrate CoA (Certificate of Analysis) is a formal document that attests to Norepinephrine Bitartrate's compliance with Norepinephrine Bitartrate specifications and serves as a tool for batch-level quality control.
Norepinephrine Bitartrate CoA mostly includes findings from lab analyses of a specific batch. For each Norepinephrine Bitartrate 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.
Norepinephrine Bitartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Norepinephrine Bitartrate EP), Norepinephrine Bitartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Norepinephrine Bitartrate USP).
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