Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Veranova: A CDMO that manages complexity with confidence.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Taste Masking
Direct Compression
Parenteral
Disintegrants & Superdisintegrants
Co-Processed Excipients
Granulation
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
24 Dec 2025
Reply
24 Sep 2025
Reply
18 Oct 2024
Reply
01 Aug 2024
Reply
11 Aug 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
86
PharmaCompass offers a list of Cisplatin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
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, and COA 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, and COA 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, 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).
Comment (3)
