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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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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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17 Nov 2020
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Urapidil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urapidil Hydrochloride, including repackagers and relabelers. The FDA regulates Urapidil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urapidil Hydrochloride 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 Urapidil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urapidil Hydrochloride supplier is an individual or a company that provides Urapidil Hydrochloride active pharmaceutical ingredient (API) or Urapidil Hydrochloride finished formulations upon request. The Urapidil Hydrochloride suppliers may include Urapidil Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Urapidil Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urapidil Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Urapidil Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Urapidil Hydrochloride DMFs exist exist since differing nations have different regulations, such as Urapidil Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urapidil Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Urapidil Hydrochloride USDMF includes data on Urapidil Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urapidil Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urapidil Hydrochloride 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 Urapidil Hydrochloride Drug Master File in Japan (Urapidil Hydrochloride JDMF) empowers Urapidil Hydrochloride 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 Urapidil Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Urapidil Hydrochloride 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 Urapidil Hydrochloride 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 Urapidil Hydrochloride Drug Master File in Korea (Urapidil Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Urapidil Hydrochloride. The MFDS reviews the Urapidil Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Urapidil Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Urapidil Hydrochloride 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 Urapidil Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Urapidil Hydrochloride suppliers with KDMF on PharmaCompass.
A Urapidil Hydrochloride written confirmation (Urapidil Hydrochloride WC) is an official document issued by a regulatory agency to a Urapidil Hydrochloride manufacturer, verifying that the manufacturing facility of a Urapidil Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Urapidil Hydrochloride APIs or Urapidil Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Urapidil Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Urapidil Hydrochloride 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 Urapidil Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Urapidil Hydrochloride 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 Urapidil Hydrochloride 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 Urapidil Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Urapidil Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Urapidil Hydrochloride suppliers with NDC on PharmaCompass.
Urapidil Hydrochloride 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 Urapidil Hydrochloride 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 Urapidil Hydrochloride GMP manufacturer or Urapidil Hydrochloride GMP API supplier for your needs.
A Urapidil Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Urapidil Hydrochloride's compliance with Urapidil Hydrochloride specifications and serves as a tool for batch-level quality control.
Urapidil Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Urapidil Hydrochloride 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.
Urapidil Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Urapidil Hydrochloride EP), Urapidil Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urapidil Hydrochloride USP).
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