Synopsis
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CEP/COS 
EU-WC
NDC
KDMF
CN
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6208
Submission : 1986-01-16
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-02
Pay. Date : 2020-03-05
DMF Number : 34341
Submission : 2019-11-22
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-13
DMF Number : 8671
Submission : 1990-07-24
Status :
Type : II
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : R0-CEP 2020-022 - Rev 01
Status : Valid
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 573
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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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
Related Excipient Companies
Minakem
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
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Coating Systems & Additives
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Lubricants & Glidants
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Co-Processed Excipients
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Verapin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Verapin, including repackagers and relabelers. The FDA regulates Verapin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Verapin 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 Verapin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Verapin supplier is an individual or a company that provides Verapin active pharmaceutical ingredient (API) or Verapin finished formulations upon request. The Verapin suppliers may include Verapin API manufacturers, exporters, distributors and traders.
click here to find a list of Verapin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Verapin DMF (Drug Master File) is a document detailing the whole manufacturing process of Verapin active pharmaceutical ingredient (API) in detail. Different forms of Verapin DMFs exist exist since differing nations have different regulations, such as Verapin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Verapin DMF submitted to regulatory agencies in the US is known as a USDMF. Verapin USDMF includes data on Verapin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Verapin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Verapin 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 Verapin Drug Master File in Japan (Verapin JDMF) empowers Verapin 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 Verapin JDMF during the approval evaluation for pharmaceutical products. At the time of Verapin 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 Verapin 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 Verapin Drug Master File in Korea (Verapin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Verapin. The MFDS reviews the Verapin KDMF as part of the drug registration process and uses the information provided in the Verapin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Verapin 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 Verapin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Verapin suppliers with KDMF on PharmaCompass.
A Verapin CEP of the European Pharmacopoeia monograph is often referred to as a Verapin Certificate of Suitability (COS). The purpose of a Verapin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Verapin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Verapin to their clients by showing that a Verapin CEP has been issued for it. The manufacturer submits a Verapin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Verapin CEP holder for the record. Additionally, the data presented in the Verapin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Verapin DMF.
A Verapin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Verapin 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 Verapin suppliers with CEP (COS) on PharmaCompass.
A Verapin written confirmation (Verapin WC) is an official document issued by a regulatory agency to a Verapin manufacturer, verifying that the manufacturing facility of a Verapin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Verapin APIs or Verapin finished pharmaceutical products to another nation, regulatory agencies frequently require a Verapin WC (written confirmation) as part of the regulatory process.
click here to find a list of Verapin 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 Verapin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Verapin 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 Verapin 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 Verapin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Verapin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Verapin suppliers with NDC on PharmaCompass.
Verapin 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 Verapin 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 Verapin GMP manufacturer or Verapin GMP API supplier for your needs.
A Verapin CoA (Certificate of Analysis) is a formal document that attests to Verapin's compliance with Verapin specifications and serves as a tool for batch-level quality control.
Verapin CoA mostly includes findings from lab analyses of a specific batch. For each Verapin 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.
Verapin may be tested according to a variety of international standards, such as European Pharmacopoeia (Verapin EP), Verapin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Verapin USP).
