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API SUPPLIERS
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USDMF
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With Virupaksha, you get a quality product with on-time delivery.
Fexofenadine Hydrochloride BP/EP/USP/JP
Date of Issue : 2025-10-01
Valid Till : 2028-09-30
Written Confirmation Number : WC-0191
Address of the Firm : Sy. No. 10, Gaddapotharam (V), Jinnaram (M), Sangareddy District 502319, Telanga...
With Virupaksha, you get a quality product with on-time delivery.
Fexofenadine Hydrochloride IP/BP/USP/Ph. Eur
Date of Issue : 2024-01-15
Valid Till : 2027-01-14
Written Confirmation Number : WC-0575
Address of the Firm : Plot No. 30 to 33 Phase-l, IDA Pashamylaram, Patancheru, IDA Pashamylaram, Sanga...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Fexofenadine Hydrochloride JP/Ph.Eur./USP
Date of Issue : 2025-07-25
Valid Till : 2028-06-04
Written Confirmation Number : WC-0043
Address of the Firm : Chemical Technical Operations — Unit V, Peddadevulapally Village, Tripuraram M...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Agalsidase Beta, Paracetamol, Diphenhydramine, Dexamethasone, Montelukast Sodium
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
Details : Agalsidase Beta is a Enzyme drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Fabry Disease.
Product Name : Undisclosed
Product Type : Enzyme
Upfront Cash : Inapplicable
August 31, 2023
Lead Product(s) : Fexofenadine Hydrochloride,Pseudophedrine HCl
Therapeutic Area : Immunology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fexofenadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Rhinitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 09, 2023
Lead Product(s) : Dupilumab,Fexofenadine Hydrochloride,Loratadine
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dupilumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pruritus.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 02, 2022
Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Ltl Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
LTL Pharma to Take Over Sanofi’s Diregura in Japan
Details : LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).
Product Name : Diregura
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 04, 2020
Lead Product(s) : Fexofenadine Hydrochloride,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fexofenadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Seasonal.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 11, 2018
Lead Product(s) : Fexofenadine Hydrochloride,Pseudophedrine HCl
Therapeutic Area : Immunology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Efficacy of Dellegra in Exposure Unit
Details : Fexofenadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Rhinitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 26, 2014
Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fexofenadine HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Seasonal.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 02, 2011
Lead Product(s) : Fexofenadine Hydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fexofenadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Rhinitis, Allergic, Perennial.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 19, 2010
Lead Product(s) : Fexofenadine Hydrochloride,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fexofenadine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Dermatitis, Atopic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 19, 2010
Lead Product(s) : Fexofenadine Hydrochloride,Pseudoephedrine
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy’s Announces the First-to-Market Launch of Over-the-Counter, Store-Brand Equivalent of ...
Details : Allegra-D (fexofenadine) is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies.
Product Name : Allegra-D
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 22, 2022
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DOSAGE - SUSPENSION;ORAL - 30MG/5ML
USFDA APPLICATION NUMBER - 201373
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
USFDA APPLICATION NUMBER - 20786
DOSAGE - TABLET;ORAL - 180MG
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET;ORAL - 30MG **Federal Registe...DOSAGE - TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
USFDA APPLICATION NUMBER - 21704
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
USFDA APPLICATION NUMBER - 21909
DOSAGE - SUSPENSION;ORAL - 30MG/5ML **Federal...DOSAGE - SUSPENSION;ORAL - 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21963
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ABOUT THIS PAGE
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PharmaCompass offers a list of Fexofenadine Hydrochloride 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 Fexofenadine Hydrochloride manufacturer or Fexofenadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fexofenadine Hydrochloride manufacturer or Fexofenadine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Fexofenadine Hydrochloride API Price utilized in the formulation of products. Fexofenadine Hydrochloride API Price is not always fixed or binding as the Fexofenadine Hydrochloride Price is obtained through a variety of data sources. The Fexofenadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE supplier is an individual or a company that provides ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE active pharmaceutical ingredient (API) or ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE finished formulations upon request. The ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE suppliers may include ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE USDMF includes data on ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE Drug Master File in Japan (ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE JDMF) empowers ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE Drug Master File in Korea (ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE. The MFDS reviews the ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE suppliers with KDMF on PharmaCompass.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP of the European Pharmacopoeia monograph is often referred to as a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE Certificate of Suitability (COS). The purpose of a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE to their clients by showing that a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP has been issued for it. The manufacturer submits a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP (COS) as part of the market authorization procedure, and it takes on the role of a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP holder for the record. Additionally, the data presented in the ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE DMF.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE suppliers with CEP (COS) on PharmaCompass.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE written confirmation (ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE WC) is an official document issued by a regulatory agency to a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE manufacturer, verifying that the manufacturing facility of a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE APIs or ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE suppliers with NDC on PharmaCompass.
ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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 ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE GMP manufacturer or ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE GMP API supplier for your needs.
A ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE's compliance with ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE 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.
ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE EP), ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ALLEGRA-D COMPONENT FEXOFENADINE HYDROCHLORIDE USP).
