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API SUPPLIERS
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USDMF
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API Imports and Exports
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Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 0.5MG/ML
USFDA APPLICATION NUMBER - 18057
DOSAGE - INJECTABLE;INJECTION - 10MG/VIAL
USFDA APPLICATION NUMBER - 18057
DOSAGE - INJECTABLE;INJECTION - 1MG/ML
USFDA APPLICATION NUMBER - 18057
DOSAGE - INJECTABLE;INJECTION - 50MG/VIAL
USFDA APPLICATION NUMBER - 18057
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
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Chewable & Orodispersible Aids
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US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Cisplatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisplatin, including repackagers and relabelers. The FDA regulates Cisplatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisplatin 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 Cisplatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisplatin supplier is an individual or a company that provides Cisplatin active pharmaceutical ingredient (API) or Cisplatin finished formulations upon request. The Cisplatin suppliers may include Cisplatin API manufacturers, exporters, distributors and traders.
click here to find a list of Cisplatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cisplatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cisplatin active pharmaceutical ingredient (API) in detail. Different forms of Cisplatin DMFs exist exist since differing nations have different regulations, such as Cisplatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cisplatin DMF submitted to regulatory agencies in the US is known as a USDMF. Cisplatin USDMF includes data on Cisplatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cisplatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cisplatin 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 Cisplatin Drug Master File in Japan (Cisplatin JDMF) empowers Cisplatin 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 Cisplatin JDMF during the approval evaluation for pharmaceutical products. At the time of Cisplatin 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 Cisplatin 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 Cisplatin Drug Master File in Korea (Cisplatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cisplatin. The MFDS reviews the Cisplatin KDMF as part of the drug registration process and uses the information provided in the Cisplatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cisplatin 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 Cisplatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cisplatin suppliers with KDMF on PharmaCompass.
A Cisplatin CEP of the European Pharmacopoeia monograph is often referred to as a Cisplatin Certificate of Suitability (COS). The purpose of a Cisplatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cisplatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cisplatin to their clients by showing that a Cisplatin CEP has been issued for it. The manufacturer submits a Cisplatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cisplatin CEP holder for the record. Additionally, the data presented in the Cisplatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cisplatin DMF.
A Cisplatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cisplatin 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 Cisplatin suppliers with CEP (COS) on PharmaCompass.
A Cisplatin written confirmation (Cisplatin WC) is an official document issued by a regulatory agency to a Cisplatin manufacturer, verifying that the manufacturing facility of a Cisplatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cisplatin APIs or Cisplatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Cisplatin WC (written confirmation) as part of the regulatory process.
click here to find a list of Cisplatin 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 Cisplatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cisplatin 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 Cisplatin 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 Cisplatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cisplatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cisplatin suppliers with NDC on PharmaCompass.
Cisplatin 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 Cisplatin 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 Cisplatin GMP manufacturer or Cisplatin GMP API supplier for your needs.
A Cisplatin CoA (Certificate of Analysis) is a formal document that attests to Cisplatin's compliance with Cisplatin specifications and serves as a tool for batch-level quality control.
Cisplatin CoA mostly includes findings from lab analyses of a specific batch. For each Cisplatin 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.
Cisplatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cisplatin EP), Cisplatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cisplatin USP).
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