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