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**Federal Regist...DOSAGE - TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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