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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 120MG **Federal Regist...DOSAGE - TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18817
DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18817
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19152
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19152
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19152
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 120MG
USFDA APPLICATION NUMBER - 19614
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 180MG
USFDA APPLICATION NUMBER - 19614
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 240MG
USFDA APPLICATION NUMBER - 19614
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 360MG
USFDA APPLICATION NUMBER - 19614
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 20943
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG
USFDA APPLICATION NUMBER - 20943
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 20943
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PharmaCompass offers a list of Verapamil 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 Verapamil Hydrochloride manufacturer or Verapamil Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Verapamil Hydrochloride manufacturer or Verapamil Hydrochloride supplier.
PharmaCompass also assists you with knowing the Verapamil Hydrochloride API Price utilized in the formulation of products. Verapamil Hydrochloride API Price is not always fixed or binding as the Verapamil Hydrochloride Price is obtained through a variety of data sources. The Verapamil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Verahexal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Verahexal, including repackagers and relabelers. The FDA regulates Verahexal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Verahexal 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 Verahexal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Verahexal supplier is an individual or a company that provides Verahexal active pharmaceutical ingredient (API) or Verahexal finished formulations upon request. The Verahexal suppliers may include Verahexal API manufacturers, exporters, distributors and traders.
click here to find a list of Verahexal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Verahexal DMF (Drug Master File) is a document detailing the whole manufacturing process of Verahexal active pharmaceutical ingredient (API) in detail. Different forms of Verahexal DMFs exist exist since differing nations have different regulations, such as Verahexal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Verahexal DMF submitted to regulatory agencies in the US is known as a USDMF. Verahexal USDMF includes data on Verahexal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Verahexal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Verahexal 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 Verahexal Drug Master File in Japan (Verahexal JDMF) empowers Verahexal 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 Verahexal JDMF during the approval evaluation for pharmaceutical products. At the time of Verahexal 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 Verahexal 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 Verahexal Drug Master File in Korea (Verahexal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Verahexal. The MFDS reviews the Verahexal KDMF as part of the drug registration process and uses the information provided in the Verahexal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Verahexal 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 Verahexal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Verahexal suppliers with KDMF on PharmaCompass.
A Verahexal CEP of the European Pharmacopoeia monograph is often referred to as a Verahexal Certificate of Suitability (COS). The purpose of a Verahexal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Verahexal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Verahexal to their clients by showing that a Verahexal CEP has been issued for it. The manufacturer submits a Verahexal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Verahexal CEP holder for the record. Additionally, the data presented in the Verahexal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Verahexal DMF.
A Verahexal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Verahexal 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 Verahexal suppliers with CEP (COS) on PharmaCompass.
A Verahexal written confirmation (Verahexal WC) is an official document issued by a regulatory agency to a Verahexal manufacturer, verifying that the manufacturing facility of a Verahexal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Verahexal APIs or Verahexal finished pharmaceutical products to another nation, regulatory agencies frequently require a Verahexal WC (written confirmation) as part of the regulatory process.
click here to find a list of Verahexal 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 Verahexal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Verahexal 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 Verahexal 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 Verahexal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Verahexal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Verahexal suppliers with NDC on PharmaCompass.
Verahexal 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 Verahexal 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 Verahexal GMP manufacturer or Verahexal GMP API supplier for your needs.
A Verahexal CoA (Certificate of Analysis) is a formal document that attests to Verahexal's compliance with Verahexal specifications and serves as a tool for batch-level quality control.
Verahexal CoA mostly includes findings from lab analyses of a specific batch. For each Verahexal 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.
Verahexal may be tested according to a variety of international standards, such as European Pharmacopoeia (Verahexal EP), Verahexal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Verahexal USP).
