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CEP/COS
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Canada
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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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 ...
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 ...
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
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
1-(2-Methoxyphenyl) Piperazine Hydrochloride
CAS Number : 5464-78-8
End Use API : Urapidil Hydrochloride
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
6-[(3-Chloropropyl) Amino]-1,3-Dimethyluracil
CAS Number : 34654-81-4
End Use API : Urapidil Hydrochloride
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
CAS Number : 6972-27-6
End Use API : Urapidil Hydrochloride
About The Company : Hebei AiYoung Pharmaceutical Group is an integrated pharmaceutical company engaged in the production, research, and sale of chemical medicines, APIs, intermedia...
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
1-(2-METHOXYPHENYL) PIPERAZINE HYDROCHLORIDE
CAS Number : 5464-78-8
End Use API : Urapidil Hydrochloride
About The Company : Hebei AiYoung Pharmaceutical Group is an integrated pharmaceutical company engaged in the production, research, and sale of chemical medicines, APIs, intermedia...
Hebei AiYoung Pharmaceutical Technology delivering high-quality APIs, intermediates, and end-to-end pharma solutions globally.
CAS Number : 35386-24-4
End Use API : Urapidil Hydrochloride
About The Company : Hebei AiYoung Pharmaceutical Group is an integrated pharmaceutical company engaged in the production, research, and sale of chemical medicines, APIs, intermedia...
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]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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REF. STANDARDS & IMPURITIES
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, 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.
A Ebrantil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebrantil, including repackagers and relabelers. The FDA regulates Ebrantil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebrantil 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 Ebrantil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ebrantil supplier is an individual or a company that provides Ebrantil active pharmaceutical ingredient (API) or Ebrantil finished formulations upon request. The Ebrantil suppliers may include Ebrantil API manufacturers, exporters, distributors and traders.
click here to find a list of Ebrantil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ebrantil DMF (Drug Master File) is a document detailing the whole manufacturing process of Ebrantil active pharmaceutical ingredient (API) in detail. Different forms of Ebrantil DMFs exist exist since differing nations have different regulations, such as Ebrantil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ebrantil DMF submitted to regulatory agencies in the US is known as a USDMF. Ebrantil USDMF includes data on Ebrantil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ebrantil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ebrantil 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 Ebrantil Drug Master File in Japan (Ebrantil JDMF) empowers Ebrantil 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 Ebrantil JDMF during the approval evaluation for pharmaceutical products. At the time of Ebrantil 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 Ebrantil 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 Ebrantil Drug Master File in Korea (Ebrantil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ebrantil. The MFDS reviews the Ebrantil KDMF as part of the drug registration process and uses the information provided in the Ebrantil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ebrantil 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 Ebrantil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ebrantil suppliers with KDMF on PharmaCompass.
A Ebrantil written confirmation (Ebrantil WC) is an official document issued by a regulatory agency to a Ebrantil manufacturer, verifying that the manufacturing facility of a Ebrantil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ebrantil APIs or Ebrantil finished pharmaceutical products to another nation, regulatory agencies frequently require a Ebrantil WC (written confirmation) as part of the regulatory process.
click here to find a list of Ebrantil 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 Ebrantil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ebrantil 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 Ebrantil 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 Ebrantil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ebrantil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ebrantil suppliers with NDC on PharmaCompass.
Ebrantil 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 Ebrantil GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ebrantil GMP manufacturer or Ebrantil GMP API supplier for your needs.
A Ebrantil CoA (Certificate of Analysis) is a formal document that attests to Ebrantil's compliance with Ebrantil specifications and serves as a tool for batch-level quality control.
Ebrantil CoA mostly includes findings from lab analyses of a specific batch. For each Ebrantil 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.
Ebrantil may be tested according to a variety of international standards, such as European Pharmacopoeia (Ebrantil EP), Ebrantil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ebrantil USP).
