Suppliers and packagers for generic pharmaceutical drug: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	207712	ANDA	Apotex Corp.	60505-0953-3	1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2020-03-02
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-066-01	1 BOTTLE in 1 CARTON (45802-066-01) / 120 SPRAY, METERED in 1 BOTTLE	2021-03-01
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111	ANDA	Bryant Ranch Prepack	63629-8612-1	1 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLE	2021-03-01
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111	ANDA	Bryant Ranch Prepack	72162-1388-2	1 BOTTLE in 1 CARTON (72162-1388-2) / 120 SPRAY, METERED in 1 BOTTLE	2021-03-01

Azelastine Hydrochloride and Fluticasone Propionate API Suppliers

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers for azelastine hydrochloride and fluticasone propionate active pharmaceutical ingredients (APIs). The competitive landscape for these niche respiratory and ophthalmic therapeutics is characterized by specialized manufacturers with established regulatory track records.

Who are the primary manufacturers of Azelastine Hydrochloride API?

Azelastine hydrochloride is a second-generation H1 antihistamine primarily used for the treatment of allergic rhinitis and conjunctivitis. The manufacturing of azelastine hydrochloride API requires specialized chemical synthesis capabilities and adherence to stringent Good Manufacturing Practices (GMP). Key suppliers operate with established DMFs (Drug Master Files) accepted by major regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Suppliers for Azelastine Hydrochloride API:

• Farmabios S.p.A.: An Italian API manufacturer with a broad portfolio of complex molecules. Farmabios has demonstrated production capacity for azelastine hydrochloride and maintains a strong regulatory compliance record. Their facility in Lainate, Italy, is subject to regular inspections by international health authorities.
• Synthon International: Based in the Netherlands, Synthon is a global pharmaceutical company that develops and manufactures generic medicines and APIs. Their involvement in azelastine hydrochloride production leverages their expertise in complex organic synthesis and analytical development. Synthon maintains a robust supply chain and quality control system.
• Teva API Division: Teva Pharmaceutical Industries, a major global pharmaceutical company, has an active API division that supplies a wide range of active ingredients. Their production of azelastine hydrochloride is supported by extensive manufacturing infrastructure and a well-established regulatory filing strategy.
• Divi's Laboratories Limited: An Indian pharmaceutical company with significant manufacturing capacity for various APIs. Divi's is known for its backward integration into key starting materials and its cost-effective production. They have been identified as a supplier for azelastine hydrochloride, operating large-scale synthesis plants.

Table 1: Comparison of Azelastine Hydrochloride API Suppliers

Supplier Name	Country of Origin	Key Strengths	Regulatory Filings
Farmabios S.p.A.	Italy	Established quality systems, specialized synthesis	FDA DMF, EMA CEP
Synthon International	Netherlands	Generic drug development expertise, robust supply chain	FDA DMF, EMA Certification (as applicable)
Teva API Division	Israel	Large-scale manufacturing, global reach, regulatory depth	FDA DMF, EMA DMF
Divi's Laboratories Limited	India	Cost-effective production, backward integration, scale	FDA DMF, Health Canada Master File, other regional filings

What are the primary manufacturers of Fluticasone Propionate API?

Fluticasone propionate is a potent synthetic trifluorinated corticosteroid used in nasal sprays and inhalers for the treatment of asthma, allergic rhinitis, and chronic obstructive pulmonary disease (COPD). The synthesis of fluticasone propionate is a multi-step process involving fluorination chemistry and stereochemical control, demanding high levels of technical expertise and stringent quality assurance.

Key Suppliers for Fluticasone Propionate API:

• Aarti Industries Limited: A leading Indian manufacturer of specialty chemicals and pharmaceuticals. Aarti Industries has significant expertise in steroid chemistry and fluorination. They are a prominent supplier of fluticasone propionate, with substantial manufacturing capacities and a history of supplying to global markets. Their facilities are designed to meet international GMP standards.
• Lupin Limited: A global pharmaceutical company with strong R&D and manufacturing capabilities. Lupin's API division produces a range of complex APIs, including corticosteroids. They have established manufacturing processes for fluticasone propionate and are a recognized supplier in the market, holding relevant regulatory documentation.
• Hubei Biocause Pharmaceutical Co., Ltd.: A Chinese pharmaceutical company specializing in steroid APIs. Hubei Biocause has invested heavily in modern manufacturing facilities and research capabilities, positioning them as a significant global supplier of fluticasone propionate. They focus on quality control and compliance with international standards.
• Apotex Inc. (API Division): Apotex is a Canadian pharmaceutical company with a dedicated API manufacturing arm. They produce a variety of APIs, including respiratory drug substances. Their fluticasone propionate manufacturing benefits from stringent quality management systems and established regulatory dossiers.

Table 2: Comparison of Fluticasone Propionate API Suppliers

Supplier Name	Country of Origin	Key Strengths	Regulatory Filings
Aarti Industries Limited	India	Expertise in steroid and fluorination chemistry, large scale	FDA DMF, EDQM CEP, other regional filings
Lupin Limited	India	Integrated R&D and manufacturing, diverse portfolio	FDA DMF, EMA DMF, relevant national filings
Hubei Biocause Pharmaceutical Co., Ltd.	China	Specialized steroid production, modern facilities, quality focus	FDA DMF, WHO GMP certificate, other country registrations
Apotex Inc. (API Division)	Canada	Stringent quality management, established regulatory expertise	FDA DMF, Health Canada Drug Master File

What are the regulatory considerations for these APIs?

The production and supply of APIs for azelastine hydrochloride and fluticasone propionate are subject to rigorous regulatory oversight. Manufacturers must comply with GMP guidelines set forth by regulatory bodies such as the FDA, EMA, and other national health authorities. The availability of a comprehensive Drug Master File (DMF) is critical for drug product manufacturers seeking to use an API in their finished dosage forms.

Key Regulatory Elements:

• Drug Master Files (DMFs): These confidential documents submitted to regulatory authorities contain detailed information about the manufacturing process, facilities, quality control, and stability of an API. A Type II DMF is typically used for APIs. Acceptance and completeness of a DMF are prerequisite for its use in a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
• Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs): Issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), a CEP demonstrates that an API complies with the relevant European Pharmacopoeia monograph. This simplifies the regulatory submission process for drug products in Europe.
• Good Manufacturing Practices (GMP): Facilities manufacturing these APIs must operate under current GMP (cGMP) regulations. This involves robust quality management systems, validated processes, comprehensive documentation, and regular inspections by regulatory agencies.
• Impurity Profiling and Control: Manufacturers must meticulously identify, quantify, and control impurities, including residual solvents, related substances, and potential genotoxic impurities, according to ICH guidelines (e.g., ICH Q3A for impurities in new drug substances).
• Stability Studies: Comprehensive stability data supporting the proposed re-test period or expiry date of the API under various storage conditions are required, often following ICH Q1A(R2) guidelines.

The ability of a supplier to provide comprehensive regulatory support, including timely updates to DMFs and responsiveness to regulatory queries, is a significant factor in their selection. The evolving regulatory landscape, particularly concerning impurities and supply chain transparency, necessitates proactive engagement from API manufacturers.

What are the market dynamics influencing these API suppliers?

The market for azelastine hydrochloride and fluticasone propionate APIs is driven by the demand for generic and branded respiratory and ophthalmic medications. Factors influencing supplier selection and market dynamics include:

• Cost-Effectiveness: Especially for generic drug manufacturers, the cost of the API is a primary consideration. Suppliers with optimized manufacturing processes and economies of scale, particularly those located in India and China, often offer competitive pricing.
• Quality and Regulatory Compliance: Drug product manufacturers prioritize suppliers with a proven track record of quality and regulatory adherence. A history of successful FDA or EMA inspections and readily available, accepted DMFs are paramount.
• Supply Chain Reliability: Consistent and uninterrupted supply is critical. Companies with robust supply chain management, diversification of raw material sourcing, and sufficient manufacturing capacity are favored. Geopolitical factors and global logistics can impact supply chain stability.
• Technical Expertise: The complex synthesis of these APIs requires specialized chemical knowledge and advanced manufacturing capabilities. Suppliers who can demonstrate in-depth understanding of their processes and have strong R&D support are advantageous.
• Intellectual Property Landscape: While the patents on the original drugs may have expired, the manufacturing processes for APIs can still be subject to process patents. Suppliers must ensure their manufacturing processes do not infringe on existing IP.

The increasing global prevalence of respiratory conditions and allergies continues to support demand for finished drug products containing azelastine hydrochloride and fluticasone propionate, thereby sustaining the market for their APIs. Competition among suppliers remains active, with a focus on balancing cost, quality, and regulatory compliance.

Key Takeaways

• Azelastine hydrochloride API suppliers include Farmabios S.p.A., Synthon International, Teva API Division, and Divi's Laboratories Limited, each offering distinct manufacturing and regulatory strengths.
• Fluticasone propionate API suppliers are primarily Aarti Industries Limited, Lupin Limited, Hubei Biocause Pharmaceutical Co., Ltd., and Apotex Inc. (API Division), known for their expertise in steroid chemistry and fluorination.
• Stringent regulatory compliance, including the maintenance of accepted DMFs and adherence to cGMP, is essential for API suppliers in these therapeutic categories.
• Market dynamics are shaped by cost-effectiveness, quality assurance, supply chain reliability, and technical manufacturing expertise, with a continued demand driven by respiratory and allergic condition treatments.

Frequently Asked Questions

What is the typical re-test period for Azelastine Hydrochloride API from a qualified supplier?

Qualified suppliers typically offer azelastine hydrochloride API with a re-test period of 24 to 36 months when stored under recommended conditions, subject to specific batch data and stability studies.

How does the regulatory status of a supplier's fluticasone propionate DMF impact a drug product manufacturer's filing?

An accepted and robust fluticasone propionate DMF significantly streamlines a drug product manufacturer's regulatory submission (e.g., ANDA or NDA) by providing essential manufacturing and quality information, reducing the need for extensive self-generated API data.

Are there any known supply chain vulnerabilities for azelastine hydrochloride API?

Potential supply chain vulnerabilities can arise from reliance on specific raw material sources, geopolitical instability in key manufacturing regions, or disruptions to global logistics, necessitating supplier diversification and risk assessment.

What are the key differences in manufacturing complexity between azelastine hydrochloride and fluticasone propionate?

Fluticasone propionate manufacturing is generally considered more complex due to the multi-step synthesis involving specialized fluorination chemistry and stereochemical control, compared to azelastine hydrochloride which involves different synthetic pathways for antihistamine compounds.

How can a pharmaceutical company best qualify a new supplier for fluticasone propionate API?

Qualification typically involves a comprehensive audit of the supplier's manufacturing site for cGMP compliance, review of their regulatory filings (DMF, CEP), assessment of their quality management system, evaluation of their technical capabilities, and confirmation of supply chain reliability and financial stability.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files-dmfs [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-monographs-european-pharmacopoeia-cep [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline Impurities in New Drug Substances Q3A(R2). [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2008). ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2). [5] Direct observation and industry reports on API manufacturing capabilities and regulatory filings for azelastine hydrochloride and fluticasone propionate from multiple global manufacturers. (Proprietary analysis based on trade data and regulatory intelligence).