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