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API SUPPLIERS
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Oseltamivir Phosphate BP/IP/USP/Ph. Eur.
Date of Issue : 2024-05-22
Valid Till : 2027-02-07
Written Confirmation Number : WC-0301
Address of the Firm : Plot No. 60A, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District...
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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Oseltamivir Phosphate
Dosage Form : Capsule
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Oseltamivir Phosphate
Dosage Form : Capsule
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Oseltamivir Phosphate
Dosage Form : Capsule
Dosage Strength : 45MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Oseltamivir Phosphate
Dosage Form : Capsule
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Oseltamivir Phosphate
Dosage Form : Oral Solution
Dosage Strength : 6MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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
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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.
A Tamiflu manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamiflu, including repackagers and relabelers. The FDA regulates Tamiflu manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamiflu 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 Tamiflu manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tamiflu supplier is an individual or a company that provides Tamiflu active pharmaceutical ingredient (API) or Tamiflu finished formulations upon request. The Tamiflu suppliers may include Tamiflu API manufacturers, exporters, distributors and traders.
click here to find a list of Tamiflu suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamiflu DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamiflu active pharmaceutical ingredient (API) in detail. Different forms of Tamiflu DMFs exist exist since differing nations have different regulations, such as Tamiflu USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamiflu DMF submitted to regulatory agencies in the US is known as a USDMF. Tamiflu USDMF includes data on Tamiflu's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamiflu USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamiflu 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 Tamiflu Drug Master File in Japan (Tamiflu JDMF) empowers Tamiflu 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 Tamiflu JDMF during the approval evaluation for pharmaceutical products. At the time of Tamiflu 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 Tamiflu 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 Tamiflu Drug Master File in Korea (Tamiflu KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamiflu. The MFDS reviews the Tamiflu KDMF as part of the drug registration process and uses the information provided in the Tamiflu KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tamiflu 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 Tamiflu API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tamiflu suppliers with KDMF on PharmaCompass.
A Tamiflu CEP of the European Pharmacopoeia monograph is often referred to as a Tamiflu Certificate of Suitability (COS). The purpose of a Tamiflu CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamiflu EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamiflu to their clients by showing that a Tamiflu CEP has been issued for it. The manufacturer submits a Tamiflu CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamiflu CEP holder for the record. Additionally, the data presented in the Tamiflu CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamiflu DMF.
A Tamiflu CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamiflu 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 Tamiflu suppliers with CEP (COS) on PharmaCompass.
A Tamiflu written confirmation (Tamiflu WC) is an official document issued by a regulatory agency to a Tamiflu manufacturer, verifying that the manufacturing facility of a Tamiflu active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tamiflu APIs or Tamiflu finished pharmaceutical products to another nation, regulatory agencies frequently require a Tamiflu WC (written confirmation) as part of the regulatory process.
click here to find a list of Tamiflu 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 Tamiflu as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tamiflu 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 Tamiflu 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 Tamiflu and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamiflu NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tamiflu suppliers with NDC on PharmaCompass.
Tamiflu 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 Tamiflu 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 Tamiflu GMP manufacturer or Tamiflu GMP API supplier for your needs.
A Tamiflu CoA (Certificate of Analysis) is a formal document that attests to Tamiflu's compliance with Tamiflu specifications and serves as a tool for batch-level quality control.
Tamiflu CoA mostly includes findings from lab analyses of a specific batch. For each Tamiflu 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.
Tamiflu may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamiflu EP), Tamiflu JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamiflu USP).
