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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Orelox
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 21-02-1992
Application Number : 1.99E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 0.8% 100Ml Oral Use
Dosage Strength : BB os suspe grat 100 ml 40 mg/5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 100Mg 12 Combined Oral Use
Dosage Strength : 12 cpr riv 100 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 200Mg 6 Combined Oral Use
Dosage Strength : 6 cpr riv 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Granulate For Oral Suspension
Dosage Strength : 0.80%
Packaging : 100 ML 0.8% - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Film-Coated Tablets
Dosage Strength : 100 mg
Packaging : 12 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Film-Coated Tablets
Dosage Strength : 200 mg
Packaging : 6 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Orelox
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2005-10-12
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Orelox Children And Infants
Dosage Form : Granule For Oral Suspension
Dosage Strength : 5ML
Packaging :
Approval Date : 2005-09-28
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Orelox
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date : 2011-05-06
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Regulatory Info :
Registration Country : India
Brand Name : Cefpodoxime Proxetil
Dosage Form : Granules
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
16
PharmaCompass offers a list of Cefpodoxime Proxetil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cefpodoxime Proxetil manufacturer or Cefpodoxime Proxetil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefpodoxime Proxetil manufacturer or Cefpodoxime Proxetil supplier.
A Cefpodoximum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefpodoximum, including repackagers and relabelers. The FDA regulates Cefpodoximum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefpodoximum 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 Cefpodoximum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cefpodoximum supplier is an individual or a company that provides Cefpodoximum active pharmaceutical ingredient (API) or Cefpodoximum finished formulations upon request. The Cefpodoximum suppliers may include Cefpodoximum API manufacturers, exporters, distributors and traders.
click here to find a list of Cefpodoximum suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cefpodoximum DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefpodoximum active pharmaceutical ingredient (API) in detail. Different forms of Cefpodoximum DMFs exist exist since differing nations have different regulations, such as Cefpodoximum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefpodoximum DMF submitted to regulatory agencies in the US is known as a USDMF. Cefpodoximum USDMF includes data on Cefpodoximum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefpodoximum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefpodoximum 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 Cefpodoximum Drug Master File in Japan (Cefpodoximum JDMF) empowers Cefpodoximum 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 Cefpodoximum JDMF during the approval evaluation for pharmaceutical products. At the time of Cefpodoximum 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 Cefpodoximum 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 Cefpodoximum Drug Master File in Korea (Cefpodoximum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefpodoximum. The MFDS reviews the Cefpodoximum KDMF as part of the drug registration process and uses the information provided in the Cefpodoximum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefpodoximum 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 Cefpodoximum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefpodoximum suppliers with KDMF on PharmaCompass.
A Cefpodoximum CEP of the European Pharmacopoeia monograph is often referred to as a Cefpodoximum Certificate of Suitability (COS). The purpose of a Cefpodoximum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefpodoximum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefpodoximum to their clients by showing that a Cefpodoximum CEP has been issued for it. The manufacturer submits a Cefpodoximum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefpodoximum CEP holder for the record. Additionally, the data presented in the Cefpodoximum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefpodoximum DMF.
A Cefpodoximum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefpodoximum 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 Cefpodoximum suppliers with CEP (COS) on PharmaCompass.
A Cefpodoximum written confirmation (Cefpodoximum WC) is an official document issued by a regulatory agency to a Cefpodoximum manufacturer, verifying that the manufacturing facility of a Cefpodoximum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefpodoximum APIs or Cefpodoximum finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefpodoximum WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefpodoximum 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 Cefpodoximum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefpodoximum 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 Cefpodoximum 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 Cefpodoximum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefpodoximum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefpodoximum suppliers with NDC on PharmaCompass.
Cefpodoximum 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 Cefpodoximum GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cefpodoximum GMP manufacturer or Cefpodoximum GMP API supplier for your needs.
A Cefpodoximum CoA (Certificate of Analysis) is a formal document that attests to Cefpodoximum's compliance with Cefpodoximum specifications and serves as a tool for batch-level quality control.
Cefpodoximum CoA mostly includes findings from lab analyses of a specific batch. For each Cefpodoximum 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.
Cefpodoximum may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefpodoximum EP), Cefpodoximum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefpodoximum USP).
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