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