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