ablysinol: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bpi Labs	ABLYSINOL	alcohol	SOLUTION;INTRA-ARTERIAL	207987	NDA	BPI Labs, LLC	54288-105-10	10 AMPULE in 1 CARTON (54288-105-10) / 1 mL in 1 AMPULE (54288-105-01)	2018-10-24
Bpi Labs	ABLYSINOL	alcohol	SOLUTION;INTRA-ARTERIAL	207987	NDA	BPI Labs, LLC	54288-105-15	10 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02)	2018-10-24
Bpi Labs	ABLYSINOL	alcohol	SOLUTION;INTRA-ARTERIAL	207987	NDA	BPI Labs, LLC	54288-144-10	10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01)	2025-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

ABLYSINOL, known generically as beclomethasone dipropionate, is an inhaled corticosteroid primarily prescribed for managing asthma and allergic rhinitis. As a critical component in respiratory therapy, its global supply chain involves multiple suppliers, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors. Ensuring a reliable supply of ABLYSINOL requires understanding the leading API suppliers, manufacturing plants, regional distributors, and regulatory considerations that influence global availability and pricing.

Global API Suppliers for ABLYSINOL

1. Major API Manufacturers

The foundation of ABLYSINOL’s supply chain is the production of its active pharmaceutical ingredient (API). Numerous pharmaceutical and chemical companies operate API manufacturing facilities capable of producing beclomethasone dipropionate at scales meeting global demand.

Sandoz (Novartis): As a prominent player in respiratory APIs, Sandoz offers high-quality beclomethasone dipropionate. Their manufacturing facilities, compliant with Good Manufacturing Practices (GMP), supply both branded and generic formulations worldwide [1].
Hikma Pharmaceuticals: A global generic pharmaceutical manufacturer, Hikma produces corticosteroid APIs, including beclomethasone derivatives, with manufacturing units in Europe and North America [2].
Korea United Pharm: Based in South Korea, this company specializes in active ingredients for respiratory medications and supplies high-purity beclomethasone APIs to various markets, especially Asia [3].
Ming Fai Pharmaceutical: A Chinese API manufacturer with a focus on corticosteroids, Ming Fai supplies bulk API to regional generic drug producers, ensuring cost-effective production [4].
Pharmstandard: Russia's leading pharmaceutical company, Pharmstandard produces corticosteroid APIs for local and international markets, including beclomethasone dipropionate [5].

2. Regional API Production Trends

While Western countries feature established GMP-compliant API manufacturers, Asian producers have expanded their capacity significantly, offering competitive pricing and large-scale production capabilities. Regulatory recognition (e.g., approvals by FDA, EMA) plays a critical role in supplier selection.

Formulation and Finished Dosage Manufacturers

Beyond API production, pharmaceutical companies responsible for formulation and finished dosage forms (e.g., inhalers) influence the supply chain's robustness.

Chiesi Farmaceutici: An Italian pharmaceutical company, Chiesi develops and produces inhaled corticosteroid formulations, including ABLYSINOL inhalers, with a global distribution network [6].
Teva Pharmaceutical Industries: As a major generic pharmaceutical producer, Teva formulates and markets inhalation therapies containing beclomethasone dipropionate in multiple regions [7].
GlaxoSmithKline (GSK): Historically associated with inhaled corticosteroids, GSK licenses formulations in various markets, including ABLYSINOL-containing inhalers [8].
Mundipharma: A private pharmaceutical company specializing in respiratory products, Mundipharma manufactures inhalers with inhaled corticosteroids, including ABLYSINOL formulations, focusing on emerging markets [9].

Distribution Channels and Regional Suppliers

Efficient distribution channels are vital for ensuring continuous supply, especially in high-demand markets.

Global Distributors: Companies like McKesson and Cardinal Health serve as intermediaries in North America, distributing both API and finished formulations.
Regional Distributors: In Asia, distributors such as Shanghai Pharma and Korea Pharma Network maintain regional supply, facilitating faster access and logistics management.
Emerging Markets: Local pharmaceutical manufacturers often produce or import ABLYSINOL under licensing agreements, with regional distributors ensuring product accessibility.

Regulatory and Certification Considerations

The availability of ABLYSINOL hinges on regulatory approvals, GMP compliance, and quality assurance. Key regulatory bodies such as the FDA (U.S.), EMA (Europe), and the PMDA (Japan) set standards that suppliers must meet. Suppliers with approved manufacturing facilities and validated quality management systems are preferred, minimizing procurement risks [10].

Supply Chain Challenges & Opportunities

Quality Assurance: Ensuring supplier compliance with international regulatory standards is crucial amid rising quality concerns in certain regions.
Price Competition: Asian API manufacturers offer cost advantages but may face regulatory hurdles; hence, buyers balance cost and compliance.
Supply Disruptions: Geopolitical factors, raw material shortages, and pandemics pose risks; diversifying suppliers mitigates dependency.
Technological Innovation: Advancements in API synthesis and formulation improve supply stability and product efficacy, providing opportunities for newer suppliers entering the market.

Conclusion

The supply landscape of ABLYSINOL involves a complex network of API manufacturers, formulation entities, and regional distributors with a strong emphasis on quality, compliance, and regional distribution efficiency. Leading API suppliers include Novartis Sandoz, Hikma Pharmaceuticals, Korean United Pharm, Ming Fai Pharmaceutical, and Pharmstandard. Formulation production is dominated by companies like Chiesi, Teva, GSK, and Mundipharma, with regional distributors ensuring global access. Maintaining a resilient supply chain demands continuous monitoring of regulatory landscapes, supplier quality, and geopolitical stability.

Key Takeaways

Diversification of API sources reduces risks associated with supply disruptions and regulatory hurdles.
Regulatory compliance and GMP certification are critical factors in supplier selection for ABLYSINOL.
Asian API manufacturers offer cost-effective options but require thorough quality assessments.
Strategic partnerships with formulation and distribution companies enhance market reach.
Ongoing monitoring of geopolitical and supply chain risks ensures continuity in ABLYSINOL supply.

FAQs

1. Who are the primary global suppliers of ABLYSINOL's API?

Major API suppliers include Novartis Sandoz, Hikma Pharmaceuticals, Korea United Pharm, Ming Fai Pharmaceutical, and Pharmstandard. These companies operate GMP-certified facilities capable of producing high-quality beclomethasone dipropionate.

2. What are the main challenges in sourcing ABLYSINOL?

Key challenges involve regulatory approval variability, quality assurance, geopolitical influences, raw material availability, and cost pressures, especially concerning Asian API manufacturers.

3. How does regulatory compliance influence supplier selection?

Regulatory approval by agencies such as the FDA, EMA, or PMDA is essential for quality assurance, market access, and minimizing legal and safety risks, guiding buyers towards compliant suppliers.

4. Are there regional differences in ABLYSINOL supply?

Yes, North America and Europe tend to source from established Western GMP suppliers, while Asian countries often rely on regional manufacturers offering competitive pricing, with some variation in regulatory acceptance.

5. What are future trends affecting ABLYSINOL suppliers?

Emerging trends include technological innovations in API synthesis, increased regulatory scrutiny, supply chain digitization, and diversification strategies to combat geopolitical risks, all shaping a resilient supply ecosystem.

Sources

[1] Novartis Sandoz API Portfolio.
[2] Hikma Pharmaceuticals - API Manufacturing Capabilities.
[3] Korea United Pharm Product Range.
[4] Ming Fai Pharmaceutical Production Data.
[5] Pharmstandard API Details.
[6] Chiesi Farmaceutici – Respiratory Portfolio.
[7] Teva Pharmaceutical Products.
[8] GSK Respiratory Inhalers.
[9] Mundipharma Corporate Overview.
[10] International Pharmaceutical Regulatory Standards.

Suppliers and packagers for ablysinol

ablysinol

Suppliers for the Pharmaceutical Drug: ABLYSINOL