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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care
Temad- We think of world-class quality.
Jai Radhe Sales is your partner for all your sourcing needs.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Neuland Laboratories- A dedicated 100% API provider.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care
About the Company : Global Pharma Healthcare, established in 1999, has nearly three decades of experience in producing APIs, finished formulations, and nutraceuticals at its EU-GMP and WHO-GMP certifi...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
About the Company : Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivative...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Tarivid
Dosage Form : Tablet
Dosage Strength : 400mg
Packaging :
Approval Date : 24-01-1992
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 : Withdrawn
Registration Country : Malta
Brand Name : Oflocet Ear
Dosage Form : Ear Drop Solution
Dosage Strength : 1.5MG
Packaging :
Approval Date : 2005-09-29
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 : Deregistered
Registration Country : Sweden
Brand Name : Tarivid
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 26-10-1990
Application Number : 1.99E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Uniflox
Dosage Form : Ear Drops, Solution, Eye Drops, Solution
Dosage Strength : 3MG/ML
Packaging :
Approval Date : 2024-08-29
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Exocin
Dosage Form : Eye Drop Solution
Dosage Strength : 3MG
Packaging :
Approval Date : 01-07-1999
Application Number : 62560
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Brand Name : Exocin
Dosage Form :
Dosage Strength : Pom Oftalm 3,5 G 0,3%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Exocin
Dosage Form :
Dosage Strength : Coll 10 Ml 0.3%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ocuflox
Dosage Form : eye drops
Dosage Strength : 0.3%
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ocuflox
Dosage Form : eye drops
Dosage Strength : 0.3%
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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Lubricants & Glidants
Disintegrants & Superdisintegrants
Topical
Film Formers & Plasticizers
Co-Processed Excipients
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Taste Masking
Vegetarian Capsules
Surfactant & Foaming Agents
Chewable & Orodispersible Aids
Rheology Modifiers
Coloring Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
41
PharmaCompass offers a list of Ofloxacin 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 Ofloxacin manufacturer or Ofloxacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ofloxacin manufacturer or Ofloxacin supplier.
A Floxal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Floxal, including repackagers and relabelers. The FDA regulates Floxal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Floxal 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 Floxal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Floxal supplier is an individual or a company that provides Floxal active pharmaceutical ingredient (API) or Floxal finished formulations upon request. The Floxal suppliers may include Floxal API manufacturers, exporters, distributors and traders.
click here to find a list of Floxal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Floxal DMF (Drug Master File) is a document detailing the whole manufacturing process of Floxal active pharmaceutical ingredient (API) in detail. Different forms of Floxal DMFs exist exist since differing nations have different regulations, such as Floxal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Floxal DMF submitted to regulatory agencies in the US is known as a USDMF. Floxal USDMF includes data on Floxal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Floxal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Floxal 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 Floxal Drug Master File in Japan (Floxal JDMF) empowers Floxal 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 Floxal JDMF during the approval evaluation for pharmaceutical products. At the time of Floxal 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 Floxal 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 Floxal Drug Master File in Korea (Floxal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Floxal. The MFDS reviews the Floxal KDMF as part of the drug registration process and uses the information provided in the Floxal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Floxal 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 Floxal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Floxal suppliers with KDMF on PharmaCompass.
A Floxal CEP of the European Pharmacopoeia monograph is often referred to as a Floxal Certificate of Suitability (COS). The purpose of a Floxal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Floxal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Floxal to their clients by showing that a Floxal CEP has been issued for it. The manufacturer submits a Floxal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Floxal CEP holder for the record. Additionally, the data presented in the Floxal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Floxal DMF.
A Floxal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Floxal 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 Floxal suppliers with CEP (COS) on PharmaCompass.
A Floxal written confirmation (Floxal WC) is an official document issued by a regulatory agency to a Floxal manufacturer, verifying that the manufacturing facility of a Floxal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Floxal APIs or Floxal finished pharmaceutical products to another nation, regulatory agencies frequently require a Floxal WC (written confirmation) as part of the regulatory process.
click here to find a list of Floxal 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 Floxal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Floxal 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 Floxal 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 Floxal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Floxal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Floxal suppliers with NDC on PharmaCompass.
Floxal 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 Floxal GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Floxal GMP manufacturer or Floxal GMP API supplier for your needs.
A Floxal CoA (Certificate of Analysis) is a formal document that attests to Floxal's compliance with Floxal specifications and serves as a tool for batch-level quality control.
Floxal CoA mostly includes findings from lab analyses of a specific batch. For each Floxal 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.
Floxal may be tested according to a variety of international standards, such as European Pharmacopoeia (Floxal EP), Floxal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Floxal USP).
