Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
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KDMF
CA, ASMF
Chirogate is a professional Prostaglandin manufacturer.
CEP/COS
JDMF
KDMF
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS
JDMF
KDMF
ASMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
CEP/COS
JDMF
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
CEP/COS
ASMF
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
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USDMF
Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2016-11-10
DMF Number : 26081
Submission : 2012-05-14
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-13
Pay. Date : 2017-02-21
DMF Number : 31372
Submission : 2017-03-14
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18343
Submission : 2005-05-24
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-11
Pay. Date : 2013-01-16
DMF Number : 26728
Submission : 2012-12-14
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-16
DMF Number : 17445
Submission : 2004-06-01
Status :
Type : II
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-15
Pay. Date : 2021-06-29
DMF Number : 34369
Submission : 2020-01-27
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-03
DMF Number : 22198
Submission : 2008-11-14
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
About the Company : Cayman Pharma, a leading European provider of cGMP prostaglandin APIs, was formed in 2006 through the merger of Cayman Chemical and NeraPharm, both with vast expertise in prostagla...
Chirogate is a professional Prostaglandin manufacturer.
About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reput...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
About the Company : With more than 30 years of experience, Gentec Pharmaceutical Group has established itself as one of the leaders in raw materials and ingredients for the food, dietary and nutrition...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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
Parenteral
Solubilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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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, Price,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.
PharmaCompass also assists you with knowing the Latanoprost API Price utilized in the formulation of products. Latanoprost API Price is not always fixed or binding as the Latanoprost Price is obtained through a variety of data sources. The Latanoprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hysite manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hysite, including repackagers and relabelers. The FDA regulates Hysite manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hysite 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 Hysite manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hysite supplier is an individual or a company that provides Hysite active pharmaceutical ingredient (API) or Hysite finished formulations upon request. The Hysite suppliers may include Hysite API manufacturers, exporters, distributors and traders.
click here to find a list of Hysite suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hysite DMF (Drug Master File) is a document detailing the whole manufacturing process of Hysite active pharmaceutical ingredient (API) in detail. Different forms of Hysite DMFs exist exist since differing nations have different regulations, such as Hysite USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hysite DMF submitted to regulatory agencies in the US is known as a USDMF. Hysite USDMF includes data on Hysite's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hysite USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hysite 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 Hysite Drug Master File in Japan (Hysite JDMF) empowers Hysite 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 Hysite JDMF during the approval evaluation for pharmaceutical products. At the time of Hysite 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 Hysite 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 Hysite Drug Master File in Korea (Hysite KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hysite. The MFDS reviews the Hysite KDMF as part of the drug registration process and uses the information provided in the Hysite KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hysite 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 Hysite API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hysite suppliers with KDMF on PharmaCompass.
A Hysite CEP of the European Pharmacopoeia monograph is often referred to as a Hysite Certificate of Suitability (COS). The purpose of a Hysite CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hysite EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hysite to their clients by showing that a Hysite CEP has been issued for it. The manufacturer submits a Hysite CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hysite CEP holder for the record. Additionally, the data presented in the Hysite CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hysite DMF.
A Hysite CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hysite 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 Hysite suppliers with CEP (COS) on PharmaCompass.
A Hysite written confirmation (Hysite WC) is an official document issued by a regulatory agency to a Hysite manufacturer, verifying that the manufacturing facility of a Hysite active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hysite APIs or Hysite finished pharmaceutical products to another nation, regulatory agencies frequently require a Hysite WC (written confirmation) as part of the regulatory process.
click here to find a list of Hysite 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 Hysite as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hysite 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 Hysite 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 Hysite and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hysite NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hysite suppliers with NDC on PharmaCompass.
Hysite 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 Hysite 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 Hysite GMP manufacturer or Hysite GMP API supplier for your needs.
A Hysite CoA (Certificate of Analysis) is a formal document that attests to Hysite's compliance with Hysite specifications and serves as a tool for batch-level quality control.
Hysite CoA mostly includes findings from lab analyses of a specific batch. For each Hysite 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.
Hysite may be tested according to a variety of international standards, such as European Pharmacopoeia (Hysite EP), Hysite JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hysite USP).
