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