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API SUPPLIERS
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USDMF
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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...
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
About the Company : With more than 40 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...
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...
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 ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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 Imports and Exports
Drugs in Development
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Expanded Access to Bimatoprost (Durysta)
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
April 21, 2022
Lead Product(s) : AGN-193408,Bimatoprost
Therapeutic Area : Ophthalmology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
Details : AGN-193408 is a drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 05, 2020
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
February 26, 2020
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
March 27, 2019
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
February 22, 2019
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Glaucoma, Open-Angle.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
July 24, 2015
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Kenneth Beer
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bimatoprost is a HPAPI drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hypotrichosis.
Product Name : Undisclosed
Product Type : HPAPI
Upfront Cash : Inapplicable
July 06, 2011
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : DURYSTA® (bimatoprost intracameral implant) is a prescription medicine to reduce eye pressure in patients with open angle glaucoma or high eye pressure (ocular hypertension), approved by the FDA in March 2020.
Product Name : Durysta
Product Type : HPAPI
Upfront Cash : Inapplicable
February 24, 2022
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracamera...
Details : DURYSTA™ is a prostaglandin analog indicated for the reduction of IOP in patients with OAG or OHT. DURYSTA™ is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant containing 10 mcg bimatoprost.
Product Name : Durysta
Product Type : HPAPI
Upfront Cash : Inapplicable
March 05, 2020
Lead Product(s) : Bimatoprost,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : A New Drug Application (NDA) for Bimatoprost SR is currently under review with the U.S. Food and Drug Administration, and if approved, has the potential to be the first and only biodegradable.
Product Name : Durysta
Product Type : HPAPI
Upfront Cash : Inapplicable
February 25, 2020
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Kirsch Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Bimatoprost 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 Bimatoprost manufacturer or Bimatoprost supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bimatoprost manufacturer or Bimatoprost supplier.
PharmaCompass also assists you with knowing the Bimatoprost API Price utilized in the formulation of products. Bimatoprost API Price is not always fixed or binding as the Bimatoprost Price is obtained through a variety of data sources. The Bimatoprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bimatoprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bimatoprost, including repackagers and relabelers. The FDA regulates Bimatoprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bimatoprost 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 Bimatoprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bimatoprost supplier is an individual or a company that provides Bimatoprost active pharmaceutical ingredient (API) or Bimatoprost finished formulations upon request. The Bimatoprost suppliers may include Bimatoprost API manufacturers, exporters, distributors and traders.
click here to find a list of Bimatoprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bimatoprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Bimatoprost active pharmaceutical ingredient (API) in detail. Different forms of Bimatoprost DMFs exist exist since differing nations have different regulations, such as Bimatoprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bimatoprost DMF submitted to regulatory agencies in the US is known as a USDMF. Bimatoprost USDMF includes data on Bimatoprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bimatoprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bimatoprost 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 Bimatoprost Drug Master File in Japan (Bimatoprost JDMF) empowers Bimatoprost 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 Bimatoprost JDMF during the approval evaluation for pharmaceutical products. At the time of Bimatoprost 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 Bimatoprost 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 Bimatoprost Drug Master File in Korea (Bimatoprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bimatoprost. The MFDS reviews the Bimatoprost KDMF as part of the drug registration process and uses the information provided in the Bimatoprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bimatoprost 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 Bimatoprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bimatoprost suppliers with KDMF on PharmaCompass.
A Bimatoprost written confirmation (Bimatoprost WC) is an official document issued by a regulatory agency to a Bimatoprost manufacturer, verifying that the manufacturing facility of a Bimatoprost active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bimatoprost APIs or Bimatoprost finished pharmaceutical products to another nation, regulatory agencies frequently require a Bimatoprost WC (written confirmation) as part of the regulatory process.
click here to find a list of Bimatoprost 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 Bimatoprost as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bimatoprost 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 Bimatoprost 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 Bimatoprost and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bimatoprost NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bimatoprost suppliers with NDC on PharmaCompass.
Bimatoprost 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 Bimatoprost 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 Bimatoprost GMP manufacturer or Bimatoprost GMP API supplier for your needs.
A Bimatoprost CoA (Certificate of Analysis) is a formal document that attests to Bimatoprost's compliance with Bimatoprost specifications and serves as a tool for batch-level quality control.
Bimatoprost CoA mostly includes findings from lab analyses of a specific batch. For each Bimatoprost 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.
Bimatoprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Bimatoprost EP), Bimatoprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bimatoprost USP).
