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  • TABLET;ORAL - 37.5MG;20MG
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG

Looking for 304-20-1 / Hydralazine Hydrochloride API manufacturers, exporters & distributors?

Hydralazine Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Hydralazine Hydrochloride

Synonyms

304-20-1, 1-hydrazinophthalazine hydrochloride, Hydralazine hcl, Apresoline, 1-hydrazinylphthalazine hydrochloride, Aiselazine

Cas Number

304-20-1

Unique Ingredient Identifier (UNII)

FD171B778Y

About Hydralazine Hydrochloride

A direct-acting vasodilator that is used as an antihypertensive agent.

Hydralazine Hydrochloride Manufacturers

A Hydralazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydralazine Hydrochloride, including repackagers and relabelers. The FDA regulates Hydralazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydralazine 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 Hydralazine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Hydralazine Hydrochloride Suppliers

A Hydralazine Hydrochloride supplier is an individual or a company that provides Hydralazine Hydrochloride active pharmaceutical ingredient (API) or Hydralazine Hydrochloride finished formulations upon request. The Hydralazine Hydrochloride suppliers may include Hydralazine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Hydralazine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Hydralazine Hydrochloride USDMF

A Hydralazine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydralazine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Hydralazine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Hydralazine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Hydralazine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Hydralazine Hydrochloride USDMF includes data on Hydralazine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydralazine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Hydralazine Hydrochloride suppliers with USDMF on PharmaCompass.

Hydralazine Hydrochloride JDMF

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 Hydrochloride Drug Master File in Japan (Hydralazine Hydrochloride JDMF) empowers Hydralazine 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 Hydralazine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Hydralazine 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 Hydralazine Hydrochloride suppliers with JDMF on PharmaCompass.

Hydralazine Hydrochloride CEP

A Hydralazine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Hydralazine Hydrochloride Certificate of Suitability (COS). The purpose of a Hydralazine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydralazine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydralazine Hydrochloride to their clients by showing that a Hydralazine Hydrochloride CEP has been issued for it. The manufacturer submits a Hydralazine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydralazine Hydrochloride CEP holder for the record. Additionally, the data presented in the Hydralazine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydralazine Hydrochloride DMF.

A Hydralazine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydralazine Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Hydralazine Hydrochloride WC

A Hydralazine Hydrochloride written confirmation (Hydralazine Hydrochloride WC) is an official document issued by a regulatory agency to a Hydralazine Hydrochloride manufacturer, verifying that the manufacturing facility of a Hydralazine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydralazine Hydrochloride APIs or Hydralazine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydralazine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Hydralazine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Hydralazine Hydrochloride NDC

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 Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Hydralazine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Hydralazine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydralazine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Hydralazine Hydrochloride suppliers with NDC on PharmaCompass.

Hydralazine Hydrochloride GMP

Hydralazine 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 Hydralazine 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 Hydralazine Hydrochloride GMP manufacturer or Hydralazine Hydrochloride GMP API supplier for your needs.

Hydralazine Hydrochloride CoA

A Hydralazine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Hydralazine Hydrochloride's compliance with Hydralazine Hydrochloride specifications and serves as a tool for batch-level quality control.

Hydralazine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Hydralazine 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.

Hydralazine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydralazine Hydrochloride EP), Hydralazine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydralazine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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