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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.005%
USFDA APPLICATION NUMBER - 20597
DOSAGE - EMULSION;OPHTHALMIC - 0.005%
USFDA APPLICATION NUMBER - 206185
Related Excipient Companies
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
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Solubilizers
API Stability Enhancers
Digital Content
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]Regulatory FDF Prices
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
RX/OTC/DISCN :
Dosage Form : Eye Drops
Dosage Strength : 0.01%
Price Per Pack (Euro) : 6.98
Published in :
Country : Italy
RX/OTC/DISCN :
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APIs
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23 Sep 2022
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13 Jul 2022
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08 Mar 2021
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23 Sep 2020
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Latanoprost API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Latanoprost manufacturer or Latanoprost supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Latanoprost manufacturer or Latanoprost supplier.
A Latanoprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Latanoprost, including repackagers and relabelers. The FDA regulates Latanoprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Latanoprost 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 Latanoprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Latanoprost supplier is an individual or a company that provides Latanoprost active pharmaceutical ingredient (API) or Latanoprost finished formulations upon request. The Latanoprost suppliers may include Latanoprost API manufacturers, exporters, distributors and traders.
click here to find a list of Latanoprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Latanoprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Latanoprost active pharmaceutical ingredient (API) in detail. Different forms of Latanoprost DMFs exist exist since differing nations have different regulations, such as Latanoprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Latanoprost DMF submitted to regulatory agencies in the US is known as a USDMF. Latanoprost USDMF includes data on Latanoprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Latanoprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Latanoprost 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 Latanoprost Drug Master File in Japan (Latanoprost JDMF) empowers Latanoprost 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 Latanoprost JDMF during the approval evaluation for pharmaceutical products. At the time of Latanoprost 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 Latanoprost 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 Latanoprost Drug Master File in Korea (Latanoprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Latanoprost. The MFDS reviews the Latanoprost KDMF as part of the drug registration process and uses the information provided in the Latanoprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Latanoprost 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 Latanoprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Latanoprost suppliers with KDMF on PharmaCompass.
A Latanoprost CEP of the European Pharmacopoeia monograph is often referred to as a Latanoprost Certificate of Suitability (COS). The purpose of a Latanoprost CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Latanoprost EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Latanoprost to their clients by showing that a Latanoprost CEP has been issued for it. The manufacturer submits a Latanoprost CEP (COS) as part of the market authorization procedure, and it takes on the role of a Latanoprost CEP holder for the record. Additionally, the data presented in the Latanoprost CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Latanoprost DMF.
A Latanoprost CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Latanoprost 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 Latanoprost suppliers with CEP (COS) on PharmaCompass.
A Latanoprost written confirmation (Latanoprost WC) is an official document issued by a regulatory agency to a Latanoprost manufacturer, verifying that the manufacturing facility of a Latanoprost active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Latanoprost APIs or Latanoprost finished pharmaceutical products to another nation, regulatory agencies frequently require a Latanoprost WC (written confirmation) as part of the regulatory process.
click here to find a list of Latanoprost 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 Latanoprost as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Latanoprost 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 Latanoprost 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 Latanoprost and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Latanoprost NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Latanoprost suppliers with NDC on PharmaCompass.
Latanoprost 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 Latanoprost GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Latanoprost GMP manufacturer or Latanoprost GMP API supplier for your needs.
A Latanoprost CoA (Certificate of Analysis) is a formal document that attests to Latanoprost's compliance with Latanoprost specifications and serves as a tool for batch-level quality control.
Latanoprost CoA mostly includes findings from lab analyses of a specific batch. For each Latanoprost 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.
Latanoprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Latanoprost EP), Latanoprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Latanoprost USP).
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