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USDMF
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Rochem International Inc
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ABOUT THIS PAGE
33
PharmaCompass offers a list of Betaxolol 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 Betaxolol manufacturer or Betaxolol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betaxolol manufacturer or Betaxolol supplier.
PharmaCompass also assists you with knowing the Betaxolol API Price utilized in the formulation of products. Betaxolol API Price is not always fixed or binding as the Betaxolol Price is obtained through a variety of data sources. The Betaxolol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betoptic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betoptic, including repackagers and relabelers. The FDA regulates Betoptic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betoptic 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 Betoptic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betoptic supplier is an individual or a company that provides Betoptic active pharmaceutical ingredient (API) or Betoptic finished formulations upon request. The Betoptic suppliers may include Betoptic API manufacturers, exporters, distributors and traders.
click here to find a list of Betoptic suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betoptic DMF (Drug Master File) is a document detailing the whole manufacturing process of Betoptic active pharmaceutical ingredient (API) in detail. Different forms of Betoptic DMFs exist exist since differing nations have different regulations, such as Betoptic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betoptic DMF submitted to regulatory agencies in the US is known as a USDMF. Betoptic USDMF includes data on Betoptic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betoptic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betoptic 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 Betoptic Drug Master File in Japan (Betoptic JDMF) empowers Betoptic 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 Betoptic JDMF during the approval evaluation for pharmaceutical products. At the time of Betoptic 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 Betoptic 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 Betoptic Drug Master File in Korea (Betoptic KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betoptic. The MFDS reviews the Betoptic KDMF as part of the drug registration process and uses the information provided in the Betoptic KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betoptic 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 Betoptic API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betoptic suppliers with KDMF on PharmaCompass.
A Betoptic CEP of the European Pharmacopoeia monograph is often referred to as a Betoptic Certificate of Suitability (COS). The purpose of a Betoptic CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betoptic EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betoptic to their clients by showing that a Betoptic CEP has been issued for it. The manufacturer submits a Betoptic CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betoptic CEP holder for the record. Additionally, the data presented in the Betoptic CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betoptic DMF.
A Betoptic CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betoptic 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 Betoptic suppliers with CEP (COS) on PharmaCompass.
A Betoptic written confirmation (Betoptic WC) is an official document issued by a regulatory agency to a Betoptic manufacturer, verifying that the manufacturing facility of a Betoptic active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betoptic APIs or Betoptic finished pharmaceutical products to another nation, regulatory agencies frequently require a Betoptic WC (written confirmation) as part of the regulatory process.
click here to find a list of Betoptic 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 Betoptic as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betoptic 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 Betoptic 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 Betoptic and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betoptic NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betoptic suppliers with NDC on PharmaCompass.
Betoptic 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 Betoptic 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 Betoptic GMP manufacturer or Betoptic GMP API supplier for your needs.
A Betoptic CoA (Certificate of Analysis) is a formal document that attests to Betoptic's compliance with Betoptic specifications and serves as a tool for batch-level quality control.
Betoptic CoA mostly includes findings from lab analyses of a specific batch. For each Betoptic 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.
Betoptic may be tested according to a variety of international standards, such as European Pharmacopoeia (Betoptic EP), Betoptic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betoptic USP).
