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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22859
Submission : 2010-06-30
Status :
Type : II
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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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Topotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Topotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topotecan Hydrochloride supplier is an individual or a company that provides Topotecan Hydrochloride active pharmaceutical ingredient (API) or Topotecan Hydrochloride finished formulations upon request. The Topotecan Hydrochloride suppliers may include Topotecan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Topotecan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topotecan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Topotecan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Topotecan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Topotecan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topotecan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Topotecan Hydrochloride USDMF includes data on Topotecan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topotecan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topotecan Hydrochloride 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 Hydrochloride Drug Master File in Korea (Topotecan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topotecan Hydrochloride. The MFDS reviews the Topotecan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Topotecan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Topotecan Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Topotecan Hydrochloride suppliers with KDMF on PharmaCompass.
A Topotecan Hydrochloride written confirmation (Topotecan Hydrochloride WC) is an official document issued by a regulatory agency to a Topotecan Hydrochloride manufacturer, verifying that the manufacturing facility of a Topotecan Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Topotecan Hydrochloride APIs or Topotecan Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Topotecan Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Topotecan Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Topotecan Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Topotecan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Topotecan Hydrochloride suppliers with NDC on PharmaCompass.
Topotecan Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Topotecan Hydrochloride GMP API supplier for your needs.
A Topotecan Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Topotecan Hydrochloride's compliance with Topotecan Hydrochloride specifications and serves as a tool for batch-level quality control.
Topotecan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Topotecan Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Topotecan Hydrochloride EP), Topotecan Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Topotecan Hydrochloride USP).
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