AZELASTINE HYDROCHLORIDE ALLERGY: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	AZELASTINE HYDROCHLORIDE ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	216421	ANDA	Walgreens	0363-0653-02	120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02)	2025-07-01
Apotex	AZELASTINE HYDROCHLORIDE ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	216421	ANDA	Walgreens	0363-0653-03	1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01)	2025-07-01
Apotex	AZELASTINE HYDROCHLORIDE ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	216421	ANDA	Walgreens	0363-0653-04	1 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02)	2025-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

Azelastine Hydrochloride is a widely used antihistamine primarily prescribed for allergic rhinitis and conjunctivitis. Its efficacy in blocking histamine receptors provides relief for nasal and ocular allergy symptoms. The global demand for azelastine hydrochloride formulations—such as nasal sprays and eye drops—has driven a complex supply chain involving multiple reputable manufacturers and suppliers. This article provides a comprehensive overview of key suppliers, evaluating their manufacturing capabilities, regulatory compliance, and distribution networks, enabling industry stakeholders and healthcare providers to make informed procurement decisions.

Overview of Azelastine Hydrochloride Market

The global azelastine hydrochloride market is characterized by a mix of generic manufacturers, dedicated pharmaceutical companies, and contract manufacturing organizations (CMOs). Market growth is driven by increasing allergy prevalence, rising awareness, and expanding OTC availability in many regions. The pharmaceutical ingredients (API) sector for azelastine hydrochloride is competitive, with several suppliers meeting international standards such as cGMP, ISO, and other quality certifications.

Primary Suppliers of Azelastine Hydrochloride API

1. GVK BIO

Profile: An integrated Contract Research & Manufacturing Organization (CRO & CMO) based in India.
Capabilities: Produces azelastine hydrochloride API under strict cGMP conditions, supplying to major global pharmaceutical companies.
Regulatory Compliance: Certified with US FDA, EMA, and other international quality standards.
Market Position: Known for reliable supply chain management and high-quality API production for both generic and branded applications.
Distribution: Supplies globally, with a strong presence in North America, Europe, and emerging markets.

2. Synthon

Profile: Dutch pharmaceutical manufacturer specializing in generic APIs and finished dosage forms.
Capabilities: Produces azelastine hydrochloride API with consistent dose purity and stability metrics.
Regulatory Compliance: Holds approvals from GMP-certified regulatory bodies, ensuring global market access.
Market Position: Acts as a strategic supplier for both branded and generic pharmaceutical companies, emphasizing cost-effectiveness and product quality.

3. Hetero Labs Limited

Profile: Indian pharmaceutical producer with extensive API manufacturing experience.
Capabilities: Offers azelastine hydrochloride with robust manufacturing processes aligned with international standards.
Regulatory Compliance: GMP-certified with FDA approvals, exporting to over 100 countries.
Market Position: Focuses on high-volume API production, catering to generic nasal spray and eye-drop formulations.

4. Zhejiang Huahai Pharmaceutical

Profile: Leading Chinese API manufacturer with large-scale production capacity.
Capabilities: Provides azelastine hydrochloride API, with a focus on cost efficiency and compliance.
Regulatory Compliance: Complies with global standards, including US FDA and EU GMP.
Market Position: Serves both domestic Chinese markets and international clients, leveraging competitive pricing.

5. Dr. Reddy's Laboratories

Profile: Multinational pharmaceutical company based in India, specializing in APIs and finished formulations.
Capabilities: Produces high-quality azelastine hydrochloride APIs for internal use and third-party supply.
Regulatory Compliance: GMP-certified, with approvals from major health authorities.
Market Position: Known for integrating API manufacturing with robust distribution networks for allergy medications.

Finished Dosage Form Suppliers and Distributors

WhileAPI suppliers produce the active pharmaceutical ingredient, finished dosage forms such as nasal sprays, eye drops, and oral formulations are completed by additional pharmaceutical manufacturers and distribution channels.

1. Sandoz (Novartis)

Supplies branded and generic azelastine hydrochloride nasal sprays globally.
Strong distribution network, especially within North America and Europe.
Emphasizes quality and consistent formulation performance.

2. Mylan (now part of Viatris)

Offers generic azelastine hydrochloride nasal spray and eye drops.
Wide availability across markets, with robust export channels.
Focuses on affordability and regulatory compliance.

3. Glenmark Pharmaceuticals

Produces ophthalmic formulations containing azelastine hydrochloride.
Serves emerging markets with cost-effective options.
Maintains compliance with regulatory standards.

4. Teva Pharmaceuticals

Distributes azelastine hydrochloride nasal and ophthalmic formulations in multiple regions.
Known for extensive reach in OTC allergy treatments.

5. Local and Regional Distributors

Numerous regional suppliers and pharmacies source azelastine hydrochloride products through authorized distributors.
These suppliers often partner with multinational pharmaceutical companies for licensed products.

Regulatory and Quality Considerations

Effective procurement hinges on supplier compliance with health authority standards. Top suppliers maintain certifications from:

US Food and Drug Administration (FDA): Ensures API manufacturing and finished product compliance.
European Medicines Agency (EMA): Mandates adherence to EU GMP regulations.
Global GMP Certification: Validates manufacturing consistency, safety, and efficacy.
ISO Certifications: Particularly ISO 9001, affirming quality management systems.

Due diligence should include verification of certificates of suitability, stability data, and batch traceability.

Future Outlook and Supplier Trends

The demand for azelastine hydrochloride is expected to grow as allergy prevalence rises globally. Suppliers investing in scalable manufacturing, sustainable practices, and advanced formulation technologies will be better positioned. Contract manufacturing will play a significant role in meeting manufacturing scale and customization needs, especially amid fluctuating supply chain dynamics and regulatory environments.

Emerging markets offer new opportunities for regional suppliers with competitive pricing and compliance integration. Additionally, the shift toward biosimilar and novel antihistamine formulations could influence market dynamics, prompting suppliers to diversify toward new delivery systems and combination therapies.

Key Takeaways

Diverse Supplier Base: Leading API manufacturers such as GVK BIO, Synthon, Hetero Labs, Zhejiang Huahai, and Dr. Reddy's are primary sources for azelastine hydrochloride, offering a broad spectrum of options aligned with international standards.
Regulatory Certification is Critical: Ensure suppliers hold GMP, FDA, EMA, and ISO certifications to mitigate supply chain risks.
Complete Supply Chain Strategy: Coordinating API procurement with finished dosage form suppliers like Sandoz, Mylan, and Teva can streamline distribution and ensure quality consistency.
Global Market Dynamics: Regional suppliers are gaining prominence, offering cost advantages and tailored supply solutions for local markets.
Innovation & Sustainability: Future suppliers should focus on sustainable manufacturing practices, scalable capacity, and innovative formulations to meet evolving market needs.

FAQs

Q1: What are the primary regions for azelastine hydrochloride API manufacturing?
A: India, China, and the Netherlands are major centers, offering large-scale manufacturing with global distribution channels.

Q2: How can procurement teams verify supplier compliance?
A: By reviewing certifications (GMP, ISO, FDA approvals), auditing manufacturing sites, and obtaining quality documentation like Stability Data and Certificates of Analysis.

Q3: Are there regional differences in supplier availability?
A: Yes. While global suppliers dominate, regional and local manufacturers often cater to specific markets with cost-effective formulations.

Q4: What role do CMOs play in the azelastine hydrochloride supply chain?
A: CMOs enable pharmaceutical companies to outsource manufacturing, ensuring capacity flexibility while maintaining quality standards.

Q5: How will market growth influence supplier strategies?
A: Suppliers will focus on capacity expansion, technological innovation, and sustainability to capitalize on rising demand, especially in emerging markets.

References

Market News and Industry Reports. Global pharmaceutical APIs market analysis (2022).
Company Websites and Certifications. GVK BIO, Synthon, Hetero Labs, Zhejiang Huahai, Dr. Reddy's.
Regulatory Guidelines. US FDA, EMA GMP documentation.
Industry Publications. Pharmaceutical technology and supply chain insights (2022).

In summary, sourcing azelastine hydrochloride demands careful consideration of supplier quality, regulatory compliance, and logistical reliability. Leading API producers in India, China, and Europe, complemented by established finished product manufacturers, constitute a resilient global supply network capable of supporting diverse market needs.

Suppliers and packagers for AZELASTINE HYDROCHLORIDE ALLERGY