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API SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
With Virupaksha, you get a quality product with on-time delivery.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38752
Submission : 2024-02-14
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39332
Submission : 2023-12-29
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43373
Submission : 2025-12-31
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36965
Submission : 2022-04-30
Status :
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37151
Submission : 2025-02-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
With Virupaksha, you get a quality product with on-time delivery.
Registration Number : 307MF10032
Registrant's Address : Plot No. : B1 and B2, IDA, Gandhinagar, Kukatpally, Medchal Malkajgiri, Hyderabad, Te...
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-11-13
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
1-(2-Ethoxyethyl)-2-(piperidin-4-yl)-1H-benzol[d]i...
CAS Number : 110963-63-8
End Use API : Bilastine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
2-[4-(2-{4-[1(2-ethoxyethyl)-1H-1,3-benzodiazol-2-...
CAS Number : 202189-78-4
End Use API : Bilastine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
2-Piperidin-4-yl-1H-benzoimidazole
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
tert-butyl 4-(1H-benzo[d]iMidazol-2-yl)piperidine-...
CAS Number : 953071-73-3
End Use API : Bilastine
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
1-(2-Ethoxy-ethyl)-2-piperidine-4-yl-1H-benzimidaz...
CAS Number : 1841081-72-8
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropano...
CAS Number : 1181267-33-3
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Ethoxyethyl-4-methylbenzenesulfonate
CAS Number : 17178-11-9
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Piperidin-4-yl-1H-benzoimidazole
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 1126-09-6
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Isonipecotic acid/4-Piperidinecarboxylic acid
CAS Number : 498-94-2
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Clatexo
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 26-04-2021
Application Number : 2.02E+13
Regulatory Info : Deregistered
Registration Country : Sweden
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bilastine Polpharma
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 27-03-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Bilastine Zentiva
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 17/05/2022
Application Number : 68401
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : ZentiBilant
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 11/11/2024
Application Number : 70026
Regulatory Info : Allowed
Registration Country : Switzerland
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bilastine Tiefenbacher
Dosage Form : Orodispersible Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 26-10-2022
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bilastine Tiefenbacher
Dosage Form : Orodispersible Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 26-10-2022
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bilastine Alfred E. Tiefenbacher
Dosage Form : Orodispersible Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 26-10-2022
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bilastine Alfred E. Tiefenbacher
Dosage Form : Orodispersible Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 26-10-2022
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Elozar
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 27-03-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Annual Reports
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Bilastine 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 Bilastine manufacturer or Bilastine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bilastine manufacturer or Bilastine supplier.
A Bilastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilastine, including repackagers and relabelers. The FDA regulates Bilastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilastine 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 Bilastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bilastine supplier is an individual or a company that provides Bilastine active pharmaceutical ingredient (API) or Bilastine finished formulations upon request. The Bilastine suppliers may include Bilastine API manufacturers, exporters, distributors and traders.
click here to find a list of Bilastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bilastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bilastine active pharmaceutical ingredient (API) in detail. Different forms of Bilastine DMFs exist exist since differing nations have different regulations, such as Bilastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bilastine DMF submitted to regulatory agencies in the US is known as a USDMF. Bilastine USDMF includes data on Bilastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bilastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bilastine 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 Bilastine Drug Master File in Japan (Bilastine JDMF) empowers Bilastine 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 Bilastine JDMF during the approval evaluation for pharmaceutical products. At the time of Bilastine 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 Bilastine suppliers with JDMF on PharmaCompass.
A Bilastine written confirmation (Bilastine WC) is an official document issued by a regulatory agency to a Bilastine manufacturer, verifying that the manufacturing facility of a Bilastine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bilastine APIs or Bilastine finished pharmaceutical products to another nation, regulatory agencies frequently require a Bilastine WC (written confirmation) as part of the regulatory process.
click here to find a list of Bilastine 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 Bilastine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bilastine 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 Bilastine 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 Bilastine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bilastine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bilastine suppliers with NDC on PharmaCompass.
Bilastine 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 Bilastine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bilastine GMP manufacturer or Bilastine GMP API supplier for your needs.
A Bilastine CoA (Certificate of Analysis) is a formal document that attests to Bilastine's compliance with Bilastine specifications and serves as a tool for batch-level quality control.
Bilastine CoA mostly includes findings from lab analyses of a specific batch. For each Bilastine 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.
Bilastine may be tested according to a variety of international standards, such as European Pharmacopoeia (Bilastine EP), Bilastine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bilastine USP).
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