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CEP/COS
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Certificate Number : CEP 2020-160 - Rev 03
Status : Valid
Issue Date : 2025-06-24
Type : Chemical
Substance Number : 901
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Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm : A-14, A-15, A-31, A-32 & A-33, M.I.D.C. Area, Chincholi, Solapur-413 255, Mahara...
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Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international ma...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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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
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PharmaCompass offers a list of Fenoterol Hydrobromide 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 Fenoterol Hydrobromide manufacturer or Fenoterol Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fenoterol Hydrobromide manufacturer or Fenoterol Hydrobromide supplier.
PharmaCompass also assists you with knowing the Fenoterol Hydrobromide API Price utilized in the formulation of products. Fenoterol Hydrobromide API Price is not always fixed or binding as the Fenoterol Hydrobromide Price is obtained through a variety of data sources. The Fenoterol Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fenoterol Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenoterol Hydrobromide, including repackagers and relabelers. The FDA regulates Fenoterol Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenoterol Hydrobromide 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 Fenoterol Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenoterol Hydrobromide supplier is an individual or a company that provides Fenoterol Hydrobromide active pharmaceutical ingredient (API) or Fenoterol Hydrobromide finished formulations upon request. The Fenoterol Hydrobromide suppliers may include Fenoterol Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Fenoterol Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Fenoterol Hydrobromide Drug Master File in Japan (Fenoterol Hydrobromide JDMF) empowers Fenoterol Hydrobromide 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 Fenoterol Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Fenoterol Hydrobromide 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 Fenoterol Hydrobromide suppliers with JDMF on PharmaCompass.
A Fenoterol Hydrobromide CEP of the European Pharmacopoeia monograph is often referred to as a Fenoterol Hydrobromide Certificate of Suitability (COS). The purpose of a Fenoterol Hydrobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fenoterol Hydrobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fenoterol Hydrobromide to their clients by showing that a Fenoterol Hydrobromide CEP has been issued for it. The manufacturer submits a Fenoterol Hydrobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fenoterol Hydrobromide CEP holder for the record. Additionally, the data presented in the Fenoterol Hydrobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fenoterol Hydrobromide DMF.
A Fenoterol Hydrobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fenoterol Hydrobromide 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 Fenoterol Hydrobromide suppliers with CEP (COS) on PharmaCompass.
A Fenoterol Hydrobromide written confirmation (Fenoterol Hydrobromide WC) is an official document issued by a regulatory agency to a Fenoterol Hydrobromide manufacturer, verifying that the manufacturing facility of a Fenoterol Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenoterol Hydrobromide APIs or Fenoterol Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenoterol Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Fenoterol Hydrobromide 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 Fenoterol Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fenoterol Hydrobromide 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 Fenoterol Hydrobromide 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 Fenoterol Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenoterol Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenoterol Hydrobromide suppliers with NDC on PharmaCompass.
Fenoterol Hydrobromide 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 Fenoterol Hydrobromide 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 Fenoterol Hydrobromide GMP manufacturer or Fenoterol Hydrobromide GMP API supplier for your needs.
A Fenoterol Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Fenoterol Hydrobromide's compliance with Fenoterol Hydrobromide specifications and serves as a tool for batch-level quality control.
Fenoterol Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Fenoterol Hydrobromide 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.
Fenoterol Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenoterol Hydrobromide EP), Fenoterol Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenoterol Hydrobromide USP).
