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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-511n
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-0511
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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Drugs in Development
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Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name : Tachyben
Dosage Form : Solution for Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name : Tachyben
Dosage Form : Solution for Injection
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name : Tachyben
Dosage Form : Solution for Injection
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
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Reply
17 Nov 2020
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REF. STANDARDS & IMPURITIES
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Urapidil 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 Urapidil Hydrochloride manufacturer or Urapidil Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urapidil Hydrochloride manufacturer or Urapidil Hydrochloride supplier.
PharmaCompass also assists you with knowing the Urapidil Hydrochloride API Price utilized in the formulation of products. Urapidil Hydrochloride API Price is not always fixed or binding as the Urapidil Hydrochloride Price is obtained through a variety of data sources. The Urapidil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Uraprene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uraprene, including repackagers and relabelers. The FDA regulates Uraprene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uraprene 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 Uraprene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Uraprene supplier is an individual or a company that provides Uraprene active pharmaceutical ingredient (API) or Uraprene finished formulations upon request. The Uraprene suppliers may include Uraprene API manufacturers, exporters, distributors and traders.
click here to find a list of Uraprene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Uraprene DMF (Drug Master File) is a document detailing the whole manufacturing process of Uraprene active pharmaceutical ingredient (API) in detail. Different forms of Uraprene DMFs exist exist since differing nations have different regulations, such as Uraprene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uraprene DMF submitted to regulatory agencies in the US is known as a USDMF. Uraprene USDMF includes data on Uraprene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uraprene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uraprene 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 Uraprene Drug Master File in Japan (Uraprene JDMF) empowers Uraprene 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 Uraprene JDMF during the approval evaluation for pharmaceutical products. At the time of Uraprene 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 Uraprene 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 Uraprene Drug Master File in Korea (Uraprene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Uraprene. The MFDS reviews the Uraprene KDMF as part of the drug registration process and uses the information provided in the Uraprene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Uraprene 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 Uraprene API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Uraprene suppliers with KDMF on PharmaCompass.
A Uraprene written confirmation (Uraprene WC) is an official document issued by a regulatory agency to a Uraprene manufacturer, verifying that the manufacturing facility of a Uraprene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Uraprene APIs or Uraprene finished pharmaceutical products to another nation, regulatory agencies frequently require a Uraprene WC (written confirmation) as part of the regulatory process.
click here to find a list of Uraprene 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 Uraprene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Uraprene 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 Uraprene 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 Uraprene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Uraprene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Uraprene suppliers with NDC on PharmaCompass.
Uraprene 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 Uraprene 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 Uraprene GMP manufacturer or Uraprene GMP API supplier for your needs.
A Uraprene CoA (Certificate of Analysis) is a formal document that attests to Uraprene's compliance with Uraprene specifications and serves as a tool for batch-level quality control.
Uraprene CoA mostly includes findings from lab analyses of a specific batch. For each Uraprene 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.
Uraprene may be tested according to a variety of international standards, such as European Pharmacopoeia (Uraprene EP), Uraprene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Uraprene USP).
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