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PharmaCompass offers a list of Hydralazine 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 Hydralazine Hydrochloride manufacturer or Hydralazine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydralazine Hydrochloride manufacturer or Hydralazine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Hydralazine Hydrochloride API Price utilized in the formulation of products. Hydralazine Hydrochloride API Price is not always fixed or binding as the Hydralazine Hydrochloride Price is obtained through a variety of data sources. The Hydralazine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A HYDRALAZINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HYDRALAZINE HCL, including repackagers and relabelers. The FDA regulates HYDRALAZINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HYDRALAZINE HCL 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 HYDRALAZINE HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A HYDRALAZINE HCL supplier is an individual or a company that provides HYDRALAZINE HCL active pharmaceutical ingredient (API) or HYDRALAZINE HCL finished formulations upon request. The HYDRALAZINE HCL suppliers may include HYDRALAZINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of HYDRALAZINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A HYDRALAZINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of HYDRALAZINE HCL active pharmaceutical ingredient (API) in detail. Different forms of HYDRALAZINE HCL DMFs exist exist since differing nations have different regulations, such as HYDRALAZINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A HYDRALAZINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. HYDRALAZINE HCL USDMF includes data on HYDRALAZINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The HYDRALAZINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of HYDRALAZINE HCL 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 HYDRALAZINE HCL Drug Master File in Japan (HYDRALAZINE HCL JDMF) empowers HYDRALAZINE HCL 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 HYDRALAZINE HCL JDMF during the approval evaluation for pharmaceutical products. At the time of HYDRALAZINE HCL 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 HYDRALAZINE HCL suppliers with JDMF on PharmaCompass.
A HYDRALAZINE HCL CEP of the European Pharmacopoeia monograph is often referred to as a HYDRALAZINE HCL Certificate of Suitability (COS). The purpose of a HYDRALAZINE HCL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of HYDRALAZINE HCL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of HYDRALAZINE HCL to their clients by showing that a HYDRALAZINE HCL CEP has been issued for it. The manufacturer submits a HYDRALAZINE HCL CEP (COS) as part of the market authorization procedure, and it takes on the role of a HYDRALAZINE HCL CEP holder for the record. Additionally, the data presented in the HYDRALAZINE HCL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the HYDRALAZINE HCL DMF.
A HYDRALAZINE HCL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. HYDRALAZINE HCL 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 HYDRALAZINE HCL suppliers with CEP (COS) on PharmaCompass.
A HYDRALAZINE HCL written confirmation (HYDRALAZINE HCL WC) is an official document issued by a regulatory agency to a HYDRALAZINE HCL manufacturer, verifying that the manufacturing facility of a HYDRALAZINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting HYDRALAZINE HCL APIs or HYDRALAZINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a HYDRALAZINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of HYDRALAZINE HCL 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 HYDRALAZINE HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for HYDRALAZINE HCL 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 HYDRALAZINE HCL 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 HYDRALAZINE HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a HYDRALAZINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of HYDRALAZINE HCL suppliers with NDC on PharmaCompass.
HYDRALAZINE HCL 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 HYDRALAZINE HCL 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 HYDRALAZINE HCL GMP manufacturer or HYDRALAZINE HCL GMP API supplier for your needs.
A HYDRALAZINE HCL CoA (Certificate of Analysis) is a formal document that attests to HYDRALAZINE HCL's compliance with HYDRALAZINE HCL specifications and serves as a tool for batch-level quality control.
HYDRALAZINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each HYDRALAZINE HCL 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.
HYDRALAZINE HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (HYDRALAZINE HCL EP), HYDRALAZINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (HYDRALAZINE HCL USP).
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