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Looking for 204255-11-8 / Oseltamivir Phosphate API manufacturers, exporters & distributors?

Oseltamivir Phosphate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Oseltamivir Phosphate

Synonyms

204255-11-8, Tamiflu, Oseltamivir (phosphate), Oseltamir phosphate, Agucort, Ro 64-0796/002

Cas Number

204255-11-8

Unique Ingredient Identifier (UNII)

4A3O49NGEZ

About Oseltamivir Phosphate

An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.

Oseltamivir Phosphate Manufacturers

A Oseltamivir Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oseltamivir Phosphate, including repackagers and relabelers. The FDA regulates Oseltamivir Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oseltamivir Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Oseltamivir Phosphate Suppliers

A Oseltamivir Phosphate supplier is an individual or a company that provides Oseltamivir Phosphate active pharmaceutical ingredient (API) or Oseltamivir Phosphate finished formulations upon request. The Oseltamivir Phosphate suppliers may include Oseltamivir Phosphate API manufacturers, exporters, distributors and traders.

click here to find a list of Oseltamivir Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Oseltamivir Phosphate USDMF

A Oseltamivir Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Oseltamivir Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Oseltamivir Phosphate DMFs exist exist since differing nations have different regulations, such as Oseltamivir Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Oseltamivir Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Oseltamivir Phosphate USDMF includes data on Oseltamivir Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oseltamivir Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Oseltamivir Phosphate suppliers with USDMF on PharmaCompass.

Oseltamivir Phosphate JDMF

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 Phosphate Drug Master File in Japan (Oseltamivir Phosphate JDMF) empowers Oseltamivir Phosphate 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 Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Oseltamivir Phosphate 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 Phosphate suppliers with JDMF on PharmaCompass.

Oseltamivir Phosphate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Oseltamivir Phosphate Drug Master File in Korea (Oseltamivir Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oseltamivir Phosphate. The MFDS reviews the Oseltamivir Phosphate KDMF as part of the drug registration process and uses the information provided in the Oseltamivir Phosphate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Oseltamivir Phosphate 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 Phosphate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Oseltamivir Phosphate suppliers with KDMF on PharmaCompass.

Oseltamivir Phosphate CEP

A Oseltamivir Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Oseltamivir Phosphate Certificate of Suitability (COS). The purpose of a Oseltamivir Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oseltamivir Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oseltamivir Phosphate to their clients by showing that a Oseltamivir Phosphate CEP has been issued for it. The manufacturer submits a Oseltamivir Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oseltamivir Phosphate CEP holder for the record. Additionally, the data presented in the Oseltamivir Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oseltamivir Phosphate DMF.

A Oseltamivir Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oseltamivir Phosphate 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 Phosphate suppliers with CEP (COS) on PharmaCompass.

Oseltamivir Phosphate WC

A Oseltamivir Phosphate written confirmation (Oseltamivir Phosphate WC) is an official document issued by a regulatory agency to a Oseltamivir Phosphate manufacturer, verifying that the manufacturing facility of a Oseltamivir Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oseltamivir Phosphate APIs or Oseltamivir Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Oseltamivir Phosphate WC (written confirmation) as part of the regulatory process.

click here to find a list of Oseltamivir Phosphate suppliers with Written Confirmation (WC) on PharmaCompass.

Oseltamivir Phosphate NDC

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 Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Oseltamivir Phosphate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Phosphate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Oseltamivir Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oseltamivir Phosphate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Oseltamivir Phosphate suppliers with NDC on PharmaCompass.

Oseltamivir Phosphate GMP

Oseltamivir Phosphate 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 Phosphate 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 Phosphate GMP manufacturer or Oseltamivir Phosphate GMP API supplier for your needs.

Oseltamivir Phosphate CoA

A Oseltamivir Phosphate CoA (Certificate of Analysis) is a formal document that attests to Oseltamivir Phosphate's compliance with Oseltamivir Phosphate specifications and serves as a tool for batch-level quality control.

Oseltamivir Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Oseltamivir Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Oseltamivir Phosphate EP), Oseltamivir Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oseltamivir Phosphate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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