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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - EQ 30MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - CAPSULE;ORAL - EQ 45MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - FOR SUSPENSION;ORAL - EQ 6MG BASE/ML
USFDA APPLICATION NUMBER - 21246
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ABOUT THIS PAGE
37
PharmaCompass offers a list of Oseltamivir Phosphate 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 Oseltamivir Phosphate manufacturer or Oseltamivir Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oseltamivir Phosphate manufacturer or Oseltamivir Phosphate supplier.
PharmaCompass also assists you with knowing the Oseltamivir Phosphate API Price utilized in the formulation of products. Oseltamivir Phosphate API Price is not always fixed or binding as the Oseltamivir Phosphate Price is obtained through a variety of data sources. The Oseltamivir Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oseltamivir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oseltamivir, including repackagers and relabelers. The FDA regulates Oseltamivir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oseltamivir 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 Oseltamivir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oseltamivir supplier is an individual or a company that provides Oseltamivir active pharmaceutical ingredient (API) or Oseltamivir finished formulations upon request. The Oseltamivir suppliers may include Oseltamivir API manufacturers, exporters, distributors and traders.
click here to find a list of Oseltamivir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oseltamivir DMF (Drug Master File) is a document detailing the whole manufacturing process of Oseltamivir active pharmaceutical ingredient (API) in detail. Different forms of Oseltamivir DMFs exist exist since differing nations have different regulations, such as Oseltamivir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oseltamivir DMF submitted to regulatory agencies in the US is known as a USDMF. Oseltamivir USDMF includes data on Oseltamivir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oseltamivir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oseltamivir 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 Oseltamivir Drug Master File in Japan (Oseltamivir JDMF) empowers Oseltamivir 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 Oseltamivir JDMF during the approval evaluation for pharmaceutical products. At the time of Oseltamivir 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 Oseltamivir 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 Oseltamivir Drug Master File in Korea (Oseltamivir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oseltamivir. The MFDS reviews the Oseltamivir KDMF as part of the drug registration process and uses the information provided in the Oseltamivir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oseltamivir 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 Oseltamivir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oseltamivir suppliers with KDMF on PharmaCompass.
A Oseltamivir CEP of the European Pharmacopoeia monograph is often referred to as a Oseltamivir Certificate of Suitability (COS). The purpose of a Oseltamivir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oseltamivir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oseltamivir to their clients by showing that a Oseltamivir CEP has been issued for it. The manufacturer submits a Oseltamivir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oseltamivir CEP holder for the record. Additionally, the data presented in the Oseltamivir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oseltamivir DMF.
A Oseltamivir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oseltamivir 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 Oseltamivir suppliers with CEP (COS) on PharmaCompass.
A Oseltamivir written confirmation (Oseltamivir WC) is an official document issued by a regulatory agency to a Oseltamivir manufacturer, verifying that the manufacturing facility of a Oseltamivir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oseltamivir APIs or Oseltamivir finished pharmaceutical products to another nation, regulatory agencies frequently require a Oseltamivir WC (written confirmation) as part of the regulatory process.
click here to find a list of Oseltamivir 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 Oseltamivir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oseltamivir 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 Oseltamivir 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 Oseltamivir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oseltamivir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oseltamivir suppliers with NDC on PharmaCompass.
Oseltamivir 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 Oseltamivir 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 Oseltamivir GMP manufacturer or Oseltamivir GMP API supplier for your needs.
A Oseltamivir CoA (Certificate of Analysis) is a formal document that attests to Oseltamivir's compliance with Oseltamivir specifications and serves as a tool for batch-level quality control.
Oseltamivir CoA mostly includes findings from lab analyses of a specific batch. For each Oseltamivir 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.
Oseltamivir may be tested according to a variety of international standards, such as European Pharmacopoeia (Oseltamivir EP), Oseltamivir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oseltamivir USP).
