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Last Updated: December 31, 2025

Suppliers and packagers for ASTEPRO ALLERGY


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ASTEPRO ALLERGY

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065-01 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON 2022-06-27
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065-02 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON 2022-06-27
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065-03 120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE 2022-06-27
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065-04 200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON 2022-06-27
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065-05 22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON 2022-06-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: ASTEPRO ALLERGY

Last updated: July 30, 2025


Introduction

ASTEPRO ALLERGY, a pivotal medication in allergy management, has gained widespread recognition for its efficacy in treating allergic rhinitis and related symptoms. As the market for allergy medications expands, identifying and understanding the key suppliers of ASTEPRO ALLERGY becomes crucial for pharmaceutical companies, healthcare providers, and supply chain stakeholders. This report offers a comprehensive overview of the primary suppliers, distribution channels, and market dynamics surrounding ASTEPRO ALLERGY, centering on ensuring supply chain integrity and strategic sourcing.


Overview of ASTEPRO ALLERGY

ASTEPRO ALLERGY primarily contains Azelastine Hydrochloride, an antihistamine used intranasally to alleviate nasal congestion, sneezing, and rhinorrhea associated with allergic rhinitis. It is marketed under various brand names worldwide and often supplied through authorized pharmaceutical manufacturers and licensed distributors. Understanding the manufacturing landscape is vital for stakeholders focused on procurement, competitive positioning, and regulatory compliance.


Primary Manufacturers of ASTEPRO ALLERGY

1. Teva Pharmaceuticals

Teva Pharmaceuticals, headquartered in Israel, is one of the leading producers of Azelastine Hydrochloride nasal sprays, including formulations akin to ASTEPRO ALLERGY. Their extensive portfolio of generic and branded medications positions them as a significant supplier globally.

  • Manufacturing Facilities & Capabilities: Teva operates multiple manufacturing plants with expertise in sterile and non-sterile pharmaceutical production, ensuring high-quality batch outputs aligned with GMP standards (Good Manufacturing Practice).
  • Market Reach: Teva supplies directly to wholesalers, pharmacies, and healthcare institutions, often holding licenses for various regional markets.

2. Sandoz (Novartis Group)

Sandoz, a division of Novartis, manufactures Azelastine-based nasal sprays, often serving as a generic supplier of ASTEPRO ALLERGY formulations in numerous countries.

  • Supply Strengths: Sandoz's global manufacturing network facilitates reliable supply and competitive pricing.
  • Distribution Agreements: Sandoz frequently collaborates with regional distributors to reach diverse markets efficiently.

3. Cipla Ltd.

An India-based pharmaceutical giant, Cipla produces Azelastine Hydrochloride nasal spray formulations, catering primarily to Asian and African markets.

  • Regulatory Approvals: Cipla's products often hold regulatory approval in emerging markets, expanding access to allergy treatment solutions.
  • Manufacturing Facilities: Equipped with state-of-the-art facilities adhering to international quality standards.

4. Other Notable Manufacturing Entities

  • Meda Pharma (a subsidiary of Mylan) has historically supplied nasal antihistamines, including Azelastine formulations.
  • Various regional manufacturers in Europe, Latin America, and Southeast Asia contribute to a fragmented supply landscape, often producing generic versions aligned with local regulatory frameworks.

Distribution Channels

Authorized Distributors and Wholesalers

Major pharmaceutical distributors serve as critical nodes, ensuring the steady supply of ASTEPRO ALLERGY to retail pharmacies, hospitals, and clinics. Prominent global distributors include:

  • McKesson Corporation
  • AmerisourceBergen
  • Cardinal Health

These companies often stock products directly from manufacturing partners or licensed regional producers.

Pharmacy Networks and Retail Chains

Pharmacies, both brick-and-mortar and online, source ASTEPRO ALLERGY through distribution contracts, with supply hinges on manufacturer distribution agreements and regional regulatory approvals.

Regional Market Variances

In some regions, regulatory barriers, patent status, and market exclusivity influence the number of suppliers and the availability of generics, impacting supply chain stability.


Regulatory and Patent Landscape

While ASTEPRO ALLERGY formulations may be subject to patent protections, many regions have authorized generic alternatives post-expiry, expanding supplier options. Patent expirations significantly influence supplier diversity, especially in mature markets like the United States and Europe, where generic manufacturers can enter and increase competition.


Market Dynamics and Supply Chain Challenges

  • Supply Disruptions: Manufacturing delays, regulatory hurdles, or raw material shortages, particularly for active pharmaceutical ingredients (APIs), pose risks to consistent supply.
  • Pricing Pressures: Increased competition from generics can shift supplier strategies toward cost reduction and capacity expansion.
  • Regulatory Compliance: Ensuring that suppliers meet regional GMP standards is critical to maintaining supply and avoiding recalls.

Strategic Considerations for Stakeholders

  • Diversification of Suppliers: To mitigate risks, sourcing from multiple manufacturers—such as Teva, Sandoz, and Cipla—can ensure supply continuity.
  • Regional Partnerships: Collaborations with regional manufacturing entities can optimize distribution effectiveness.
  • Monitoring Patent Status: Awareness of patent expiration timelines informs procurement strategies for generics.

Key Takeaways

  • Major global suppliers of ASTEPRO ALLERGY include Teva Pharmaceuticals, Sandoz, and Cipla, underwriting a broad spectrum of regional availability.
  • The supply chain relies heavily on authorized distributors and regional manufacturers, with supply stability influenced by patent status, raw material access, and regulatory environment.
  • As patent protections expire and generic competition intensifies, supplier diversity will become increasingly essential for ensuring reliable access.
  • Market dynamics such as regulatory shifts and raw material shortages continue to challenge supply continuity, underscoring the importance of strategic procurement approaches.
  • Stringent adherence to GMP standards and regional compliance remains a cornerstone of supplier selection and market entry.

FAQs

Q1: Who are the leading manufacturers of ASTEPRO ALLERGY worldwide?
A1: The primary manufacturers include Teva Pharmaceuticals, Sandoz (Novartis), and Cipla, each supplying the medication across different regions.

Q2: How does patent status affect supplier options for ASTEPRO ALLERGY?
A2: Patent expirations enable generic manufacturers to enter the market, increasing supplier options and often leading to price reductions and increased supply security.

Q3: What are the main risks to ASTEPRO ALLERGY supply chains?
A3: Risks include raw material shortages, manufacturing delays, regulatory barriers, and geopolitical factors affecting export/import policies.

Q4: Can regional manufacturers supply ASTEPRO ALLERGY in multiple markets?
A4: Yes, regional manufacturers with appropriate regulatory approvals can supply local markets, but their reach depends on licensing agreements and regional regulations.

Q5: How can healthcare providers ensure access to ASTEPRO ALLERGY amid supply uncertainties?
A5: By establishing diverse supplier relationships, monitoring patent statuses, and engaging with authorized distributors, providers can improve supply reliability.


References

  1. [1] European Medicines Agency. "Azelastine-containing medicines." EMA Reports.
  2. [2] U.S. Food and Drug Administration. "Drug Approvals and Patents." FDA Database.
  3. [3] Pharmaceutical Technology. "Global manufacturing landscape for antihistamines." April 2022.
  4. [4] IQVIA. "Market Reports on Allergy Medications." 2023.
  5. [5] World Health Organization. "Guidelines on Good Manufacturing Practices." 2019.

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