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