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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/M...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 200199
DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 200199
DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 200199
DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
USFDA APPLICATION NUMBER - 200582
DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/VIAL
USFDA APPLICATION NUMBER - 20671
DOSAGE - CAPSULE;ORAL - EQ 0.25MG BASE
USFDA APPLICATION NUMBER - 20981
DOSAGE - CAPSULE;ORAL - EQ 1MG BASE
USFDA APPLICATION NUMBER - 20981
Related Excipient Companies
Rochem International Inc
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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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Topotecan Hydrochloride 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 Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier.
PharmaCompass also assists you with knowing the Topotecan Hydrochloride API Price utilized in the formulation of products. Topotecan Hydrochloride API Price is not always fixed or binding as the Topotecan Hydrochloride Price is obtained through a variety of data sources. The Topotecan Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Topotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan, including repackagers and relabelers. The FDA regulates Topotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan 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 Topotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topotecan supplier is an individual or a company that provides Topotecan active pharmaceutical ingredient (API) or Topotecan finished formulations upon request. The Topotecan suppliers may include Topotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Topotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topotecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Topotecan active pharmaceutical ingredient (API) in detail. Different forms of Topotecan DMFs exist exist since differing nations have different regulations, such as Topotecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topotecan DMF submitted to regulatory agencies in the US is known as a USDMF. Topotecan USDMF includes data on Topotecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topotecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topotecan suppliers with USDMF 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 Topotecan Drug Master File in Korea (Topotecan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topotecan. The MFDS reviews the Topotecan KDMF as part of the drug registration process and uses the information provided in the Topotecan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Topotecan 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 Topotecan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Topotecan suppliers with KDMF on PharmaCompass.
A Topotecan written confirmation (Topotecan WC) is an official document issued by a regulatory agency to a Topotecan manufacturer, verifying that the manufacturing facility of a Topotecan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Topotecan APIs or Topotecan finished pharmaceutical products to another nation, regulatory agencies frequently require a Topotecan WC (written confirmation) as part of the regulatory process.
click here to find a list of Topotecan 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 Topotecan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Topotecan 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 Topotecan 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 Topotecan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Topotecan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Topotecan suppliers with NDC on PharmaCompass.
Topotecan 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 Topotecan 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 Topotecan GMP manufacturer or Topotecan GMP API supplier for your needs.
A Topotecan CoA (Certificate of Analysis) is a formal document that attests to Topotecan's compliance with Topotecan specifications and serves as a tool for batch-level quality control.
Topotecan CoA mostly includes findings from lab analyses of a specific batch. For each Topotecan 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.
Topotecan may be tested according to a variety of international standards, such as European Pharmacopoeia (Topotecan EP), Topotecan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Topotecan USP).
