Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20408
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE
USFDA APPLICATION NUMBER - 20869
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
Parenteral
Granulation
Co-Processed Excipients
API Stability Enhancers
Solubilizers
Topical
Controlled & Modified Release
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
42
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dorzolamide, including repackagers and relabelers. The FDA regulates Dorzolamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dorzolamide 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dorzolamide supplier is an individual or a company that provides Dorzolamide active pharmaceutical ingredient (API) or Dorzolamide finished formulations upon request. The Dorzolamide suppliers may include Dorzolamide API manufacturers, exporters, distributors and traders.
click here to find a list of Dorzolamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dorzolamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Dorzolamide active pharmaceutical ingredient (API) in detail. Different forms of Dorzolamide DMFs exist exist since differing nations have different regulations, such as Dorzolamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dorzolamide DMF submitted to regulatory agencies in the US is known as a USDMF. Dorzolamide USDMF includes data on Dorzolamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dorzolamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dorzolamide 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 Dorzolamide Drug Master File in Japan (Dorzolamide JDMF) empowers Dorzolamide 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Dorzolamide 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 Dorzolamide 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 Dorzolamide Drug Master File in Korea (Dorzolamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dorzolamide. The MFDS reviews the Dorzolamide KDMF as part of the drug registration process and uses the information provided in the Dorzolamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dorzolamide 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dorzolamide suppliers with KDMF on PharmaCompass.
A Dorzolamide CEP of the European Pharmacopoeia monograph is often referred to as a Dorzolamide Certificate of Suitability (COS). The purpose of a Dorzolamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dorzolamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dorzolamide to their clients by showing that a Dorzolamide CEP has been issued for it. The manufacturer submits a Dorzolamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dorzolamide CEP holder for the record. Additionally, the data presented in the Dorzolamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dorzolamide DMF.
A Dorzolamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dorzolamide 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 Dorzolamide suppliers with CEP (COS) on PharmaCompass.
A Dorzolamide written confirmation (Dorzolamide WC) is an official document issued by a regulatory agency to a Dorzolamide manufacturer, verifying that the manufacturing facility of a Dorzolamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dorzolamide APIs or Dorzolamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Dorzolamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Dorzolamide 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 Dorzolamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dorzolamide 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dorzolamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dorzolamide suppliers with NDC on PharmaCompass.
Dorzolamide 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 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 GMP manufacturer or Dorzolamide GMP API supplier for your needs.
A Dorzolamide CoA (Certificate of Analysis) is a formal document that attests to Dorzolamide's compliance with Dorzolamide specifications and serves as a tool for batch-level quality control.
Dorzolamide CoA mostly includes findings from lab analyses of a specific batch. For each Dorzolamide 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Dorzolamide EP), Dorzolamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dorzolamide USP).
