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VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
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Health Canada Patents
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9601
Submission : 1992-03-26
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Cisplatin 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 Cisplatin manufacturer or Cisplatin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cisplatin manufacturer or Cisplatin supplier.
PharmaCompass also assists you with knowing the Cisplatin API Price utilized in the formulation of products. Cisplatin API Price is not always fixed or binding as the Cisplatin Price is obtained through a variety of data sources. The Cisplatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PLATINOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PLATINOL, including repackagers and relabelers. The FDA regulates PLATINOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PLATINOL 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 PLATINOL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PLATINOL supplier is an individual or a company that provides PLATINOL active pharmaceutical ingredient (API) or PLATINOL finished formulations upon request. The PLATINOL suppliers may include PLATINOL API manufacturers, exporters, distributors and traders.
click here to find a list of PLATINOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PLATINOL DMF (Drug Master File) is a document detailing the whole manufacturing process of PLATINOL active pharmaceutical ingredient (API) in detail. Different forms of PLATINOL DMFs exist exist since differing nations have different regulations, such as PLATINOL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PLATINOL DMF submitted to regulatory agencies in the US is known as a USDMF. PLATINOL USDMF includes data on PLATINOL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PLATINOL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PLATINOL 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 PLATINOL Drug Master File in Japan (PLATINOL JDMF) empowers PLATINOL 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 PLATINOL JDMF during the approval evaluation for pharmaceutical products. At the time of PLATINOL 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 PLATINOL 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 PLATINOL Drug Master File in Korea (PLATINOL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PLATINOL. The MFDS reviews the PLATINOL KDMF as part of the drug registration process and uses the information provided in the PLATINOL KDMF to evaluate the safety and efficacy of the drug.
After submitting a PLATINOL 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 PLATINOL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PLATINOL suppliers with KDMF on PharmaCompass.
A PLATINOL CEP of the European Pharmacopoeia monograph is often referred to as a PLATINOL Certificate of Suitability (COS). The purpose of a PLATINOL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PLATINOL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PLATINOL to their clients by showing that a PLATINOL CEP has been issued for it. The manufacturer submits a PLATINOL CEP (COS) as part of the market authorization procedure, and it takes on the role of a PLATINOL CEP holder for the record. Additionally, the data presented in the PLATINOL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PLATINOL DMF.
A PLATINOL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PLATINOL 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 PLATINOL suppliers with CEP (COS) on PharmaCompass.
A PLATINOL written confirmation (PLATINOL WC) is an official document issued by a regulatory agency to a PLATINOL manufacturer, verifying that the manufacturing facility of a PLATINOL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PLATINOL APIs or PLATINOL finished pharmaceutical products to another nation, regulatory agencies frequently require a PLATINOL WC (written confirmation) as part of the regulatory process.
click here to find a list of PLATINOL 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 PLATINOL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PLATINOL 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 PLATINOL 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 PLATINOL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PLATINOL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PLATINOL suppliers with NDC on PharmaCompass.
PLATINOL 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 PLATINOL 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 PLATINOL GMP manufacturer or PLATINOL GMP API supplier for your needs.
A PLATINOL CoA (Certificate of Analysis) is a formal document that attests to PLATINOL's compliance with PLATINOL specifications and serves as a tool for batch-level quality control.
PLATINOL CoA mostly includes findings from lab analyses of a specific batch. For each PLATINOL 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.
PLATINOL may be tested according to a variety of international standards, such as European Pharmacopoeia (PLATINOL EP), PLATINOL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PLATINOL USP).
