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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Arformoterol Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arformoterol Tartrate, including repackagers and relabelers. The FDA regulates Arformoterol Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arformoterol Tartrate 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 Arformoterol Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arformoterol Tartrate supplier is an individual or a company that provides Arformoterol Tartrate active pharmaceutical ingredient (API) or Arformoterol Tartrate finished formulations upon request. The Arformoterol Tartrate suppliers may include Arformoterol Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Arformoterol Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arformoterol Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Arformoterol Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Arformoterol Tartrate DMFs exist exist since differing nations have different regulations, such as Arformoterol Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arformoterol Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Arformoterol Tartrate USDMF includes data on Arformoterol Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arformoterol Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arformoterol Tartrate 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 Arformoterol Tartrate Drug Master File in Korea (Arformoterol Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Arformoterol Tartrate. The MFDS reviews the Arformoterol Tartrate KDMF as part of the drug registration process and uses the information provided in the Arformoterol Tartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Arformoterol Tartrate 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 Arformoterol Tartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Arformoterol Tartrate suppliers with KDMF on PharmaCompass.
A Arformoterol Tartrate written confirmation (Arformoterol Tartrate WC) is an official document issued by a regulatory agency to a Arformoterol Tartrate manufacturer, verifying that the manufacturing facility of a Arformoterol Tartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Arformoterol Tartrate APIs or Arformoterol Tartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Arformoterol Tartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Arformoterol Tartrate 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 Arformoterol Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Arformoterol Tartrate 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 Arformoterol Tartrate 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 Arformoterol Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Arformoterol Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Arformoterol Tartrate suppliers with NDC on PharmaCompass.
Arformoterol Tartrate 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 Arformoterol Tartrate 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 Arformoterol Tartrate GMP manufacturer or Arformoterol Tartrate GMP API supplier for your needs.
A Arformoterol Tartrate CoA (Certificate of Analysis) is a formal document that attests to Arformoterol Tartrate's compliance with Arformoterol Tartrate specifications and serves as a tool for batch-level quality control.
Arformoterol Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Arformoterol Tartrate 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.
Arformoterol Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Arformoterol Tartrate EP), Arformoterol Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Arformoterol Tartrate USP).
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