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API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20007
DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20103
DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20605
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ondansetron 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 Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ondansetron Hydrochloride API Price utilized in the formulation of products. Ondansetron Hydrochloride API Price is not always fixed or binding as the Ondansetron Hydrochloride Price is obtained through a variety of data sources. The Ondansetron Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zensana manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zensana, including repackagers and relabelers. The FDA regulates Zensana manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zensana 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 Zensana manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zensana supplier is an individual or a company that provides Zensana active pharmaceutical ingredient (API) or Zensana finished formulations upon request. The Zensana suppliers may include Zensana API manufacturers, exporters, distributors and traders.
click here to find a list of Zensana suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zensana DMF (Drug Master File) is a document detailing the whole manufacturing process of Zensana active pharmaceutical ingredient (API) in detail. Different forms of Zensana DMFs exist exist since differing nations have different regulations, such as Zensana USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zensana DMF submitted to regulatory agencies in the US is known as a USDMF. Zensana USDMF includes data on Zensana's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zensana USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zensana 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 Zensana Drug Master File in Japan (Zensana JDMF) empowers Zensana 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 Zensana JDMF during the approval evaluation for pharmaceutical products. At the time of Zensana 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 Zensana 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 Zensana Drug Master File in Korea (Zensana KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zensana. The MFDS reviews the Zensana KDMF as part of the drug registration process and uses the information provided in the Zensana KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zensana 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 Zensana API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zensana suppliers with KDMF on PharmaCompass.
A Zensana CEP of the European Pharmacopoeia monograph is often referred to as a Zensana Certificate of Suitability (COS). The purpose of a Zensana CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zensana EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zensana to their clients by showing that a Zensana CEP has been issued for it. The manufacturer submits a Zensana CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zensana CEP holder for the record. Additionally, the data presented in the Zensana CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zensana DMF.
A Zensana CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zensana 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 Zensana suppliers with CEP (COS) on PharmaCompass.
A Zensana written confirmation (Zensana WC) is an official document issued by a regulatory agency to a Zensana manufacturer, verifying that the manufacturing facility of a Zensana active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zensana APIs or Zensana finished pharmaceutical products to another nation, regulatory agencies frequently require a Zensana WC (written confirmation) as part of the regulatory process.
click here to find a list of Zensana 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 Zensana as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zensana 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 Zensana 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 Zensana and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zensana NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zensana suppliers with NDC on PharmaCompass.
Zensana 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 Zensana 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 Zensana GMP manufacturer or Zensana GMP API supplier for your needs.
A Zensana CoA (Certificate of Analysis) is a formal document that attests to Zensana's compliance with Zensana specifications and serves as a tool for batch-level quality control.
Zensana CoA mostly includes findings from lab analyses of a specific batch. For each Zensana 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.
Zensana may be tested according to a variety of international standards, such as European Pharmacopoeia (Zensana EP), Zensana JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zensana USP).
