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