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PharmaCompass offers a list of Salmeterol Xinafoate 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 Salmeterol Xinafoate manufacturer or Salmeterol Xinafoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salmeterol Xinafoate manufacturer or Salmeterol Xinafoate supplier.
PharmaCompass also assists you with knowing the Salmeterol Xinafoate API Price utilized in the formulation of products. Salmeterol Xinafoate API Price is not always fixed or binding as the Salmeterol Xinafoate Price is obtained through a variety of data sources. The Salmeterol Xinafoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Salmeterol Xinafoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Salmeterol Xinafoate, including repackagers and relabelers. The FDA regulates Salmeterol Xinafoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Salmeterol Xinafoate 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 Salmeterol Xinafoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Salmeterol Xinafoate supplier is an individual or a company that provides Salmeterol Xinafoate active pharmaceutical ingredient (API) or Salmeterol Xinafoate finished formulations upon request. The Salmeterol Xinafoate suppliers may include Salmeterol Xinafoate API manufacturers, exporters, distributors and traders.
click here to find a list of Salmeterol Xinafoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Salmeterol Xinafoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Salmeterol Xinafoate active pharmaceutical ingredient (API) in detail. Different forms of Salmeterol Xinafoate DMFs exist exist since differing nations have different regulations, such as Salmeterol Xinafoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Salmeterol Xinafoate DMF submitted to regulatory agencies in the US is known as a USDMF. Salmeterol Xinafoate USDMF includes data on Salmeterol Xinafoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Salmeterol Xinafoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Salmeterol Xinafoate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Salmeterol Xinafoate Drug Master File in Japan (Salmeterol Xinafoate JDMF) empowers Salmeterol Xinafoate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Salmeterol Xinafoate JDMF during the approval evaluation for pharmaceutical products. At the time of Salmeterol Xinafoate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Salmeterol Xinafoate suppliers with JDMF on PharmaCompass.
A Salmeterol Xinafoate CEP of the European Pharmacopoeia monograph is often referred to as a Salmeterol Xinafoate Certificate of Suitability (COS). The purpose of a Salmeterol Xinafoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Salmeterol Xinafoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Salmeterol Xinafoate to their clients by showing that a Salmeterol Xinafoate CEP has been issued for it. The manufacturer submits a Salmeterol Xinafoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Salmeterol Xinafoate CEP holder for the record. Additionally, the data presented in the Salmeterol Xinafoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Salmeterol Xinafoate DMF.
A Salmeterol Xinafoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Salmeterol Xinafoate 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 Salmeterol Xinafoate suppliers with CEP (COS) on PharmaCompass.
A Salmeterol Xinafoate written confirmation (Salmeterol Xinafoate WC) is an official document issued by a regulatory agency to a Salmeterol Xinafoate manufacturer, verifying that the manufacturing facility of a Salmeterol Xinafoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Salmeterol Xinafoate APIs or Salmeterol Xinafoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Salmeterol Xinafoate WC (written confirmation) as part of the regulatory process.
click here to find a list of Salmeterol Xinafoate 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 Salmeterol Xinafoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Salmeterol Xinafoate 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 Salmeterol Xinafoate 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 Salmeterol Xinafoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Salmeterol Xinafoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Salmeterol Xinafoate suppliers with NDC on PharmaCompass.
Salmeterol Xinafoate 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 Salmeterol Xinafoate 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 Salmeterol Xinafoate GMP manufacturer or Salmeterol Xinafoate GMP API supplier for your needs.
A Salmeterol Xinafoate CoA (Certificate of Analysis) is a formal document that attests to Salmeterol Xinafoate's compliance with Salmeterol Xinafoate specifications and serves as a tool for batch-level quality control.
Salmeterol Xinafoate CoA mostly includes findings from lab analyses of a specific batch. For each Salmeterol Xinafoate 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.
Salmeterol Xinafoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Salmeterol Xinafoate EP), Salmeterol Xinafoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Salmeterol Xinafoate USP).
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