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**Federal Regist...DOSAGE - TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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