TEXACORT: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	TEXACORT	hydrocortisone	SOLUTION;TOPICAL	081271	ANDA	Mission Pharmacal Company	0178-0455-01	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR	2011-12-15
Mission Pharma	TEXACORT	hydrocortisone	SOLUTION;TOPICAL	081271	ANDA	Trifluent Pharma LLC	73352-455-01	1 BOTTLE, WITH APPLICATOR in 1 CARTON (73352-455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR	2024-11-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

TEXACORT, a trademarked corticosteroid formulation, is used primarily in the management of inflammatory and allergic respiratory conditions. Its active ingredient, beclomethasone dipropionate, is a potent inhaled corticosteroid (ICS) recognized for its efficacy in reducing airway inflammation in diseases such as asthma and allergic rhinitis. As the demand for TEXACORT rises globally due to increasing prevalence of respiratory disorders, understanding its supply chain becomes essential for healthcare providers, pharmaceutical companies, and investors seeking reliable sourcing options and supply stability. This article provides an in-depth analysis of the key suppliers involved in the production and distribution of TEXACORT, highlighting manufacturing sources, regional suppliers, and market dynamics.

Active Pharmaceutical Ingredient (API) Supply for TEXACORT

Beclomethasone Dipropionate: The Core API

The efficacy of TEXACORT hinges on the quality and consistency of its API: beclomethasone dipropionate. The API's quality, purity, and bioavailability are critical and are regulated by international standards such as the Pharmacopeia (USP, BP, EP). The primary suppliers of beclomethasone dipropionate are multinational pharmaceutical ingredient manufacturers, many of which operate extensive R&D and manufacturing facilities across Asia, Europe, and North America.

Key API Manufacturers

Haldiya Pharmaceuticals (India)
A prominent API manufacturer, Haldiya Pharmaceuticals specializes in corticosteroids, including beclomethasone dipropionate. Its production facilities are accredited with GMP compliance and ISO certifications, serving both domestic and international markets [1].
Mundipharma International GmbH & Co. KG (Germany)
Mundipharma, part of the Purdue Pharma group, supplies pharmaceutical ingredients globally, focusing on high-quality corticosteroids. Their focus is on integration within proprietary formulations such as TEXACORT [2].
Shanghai Desano Pharmaceutical Co., Ltd. (China)
A leading Chinese manufacturer, Desano is known for producing pharmaceutically pure corticosteroid APIs, including beclomethasone dipropionate, utilizing advanced synthesis and purification techniques [3].
Aergon Pharma (Switzerland)
Aergon provides high-quality corticosteroid APIs with a focus on pharmaceutical stability and bioequivalence, supplying to major inhalation product developers [4].
Cipla Limited (India)
Besides being a contract manufacturer, Cipla produces its own corticosteroid APIs, including beclomethasone derivatives, geared towards their inhaler product lines, including TEXACORT.

These API suppliers comply with international regulatory standards and maintain stringent quality controls, essential to ensuring the safety, efficacy, and consistency of inhaled corticosteroid formulations like TEXACORT.

Inhalation Device and Formulation Suppliers

TEXACORT’s delivery system involves metered-dose inhalers (MDIs) or dry powder inhalers (DPIs). The formulation’s stability, particle size, and dosing accuracy depend heavily on device manufacturers and formulation specialists.

Device Manufacturers

AstraZeneca (UK/Global)
As a pioneer in inhalation devices, AstraZeneca supplies inhaler platforms compatible with corticosteroid formulations. Their expertise in device engineering ensures consistent drug delivery for products like TEXACORT.
GlaxoSmithKline (GSK) (UK)
GSK manufactures well-established inhaler devices, including those used for beclomethasone-based products. Their technological innovation in breath-actuated inhalers supports precise dosing and ease of use.
Valois SAS (France)
Specializes in device customization and has collaborated with pharmaceutical companies to develop specific inhalation devices tailored for corticosteroid formulations.

Contract Manufacturers and Distributors

Third-party Contract Manufacturing Organizations (CMOs) and distributors facilitate the global supply chain of TEXACORT, helping pharmaceutical firms extend their manufacturing capacity and reach emerging markets.

Cipla Ltd. (India)
A key CMO providing formulation and bottling services for inhalation products, with extensive export capabilities.
Sun Pharma Advanced Research Company Ltd. (India)
Provides manufacturing services for inhalable corticosteroid formulations, including stability and packaging solutions.
Viatris (US/Global)
An emerging supplier offering inhaler manufacturing, distribution, and logistics services across multiple regions.

Regional Market Dynamics and Supply Chain Considerations

Asia-Pacific

Dominates global API production, primarily through China and India.
Key suppliers such as Shanghai Desano and Cipla facilitate cost-effective manufacturing.
High regulatory compliance but variability in quality standards necessitates due diligence.

Europe

Hosts high-quality API production facilities, with companies like Mundipharma and Aergon Pharma.
Emphasizes regulatory compliance with EMA standards, often preferred for regulated markets.

North America

Limited API manufacturing, relying heavily on imports from Asia and Europe.
Focus on sourcing from suppliers with FDA ce certifications.

Supply Chain Risks

Regulatory Delays: Stringent quality controls can cause supply delays, especially for APIs sourced from non-compliant facilities.
Raw Material Fluctuations: Variability in the availability of raw materials impacts API production.
Geopolitical Factors: Trade tensions may disrupt supply chains, prompting companies to diversify suppliers.

Market Trends and Future Outlook

Increasing adoption of biosimilar corticosteroids may influence supplier dynamics.
Growing demand for inhalers in emerging markets drives supply chain expansion.
Regulatory pressures favor high-quality, certified suppliers, potentially reducing reliance on lower-cost but less regulated sources.
Investments in sustainable manufacturing practices are becoming a priority to mitigate environmental impact.

Conclusion

The supply chain for TEXACORT involves a complex network of API manufacturers, device producers, and logistics providers, predominantly located across Asia, Europe, and North America. Ensuring consistent supply and high quality hinges on sourcing from reputable suppliers complying with international standards. Key API suppliers GMBH, Desano, Cipla, and Aergon Pharma dominate the landscape, supported by device manufacturers like AstraZeneca and GSK. Diversification and rigorous quality assurance remain crucial amid geopolitical and regulatory challenges.

Key Takeaways

API Quality is Paramount: Select suppliers with GMP accreditation and strong regulatory compliance for API sourcing.
Diversify Suppliers: Mitigate supply risks by engaging with multiple reputable manufacturers across regions.
Monitor Regulatory Developments: Stay updated on international standards, which influence supplier qualification and procurement processes.
Invest in Supply Chain Transparency: Ensure traceability from raw materials to finished inhalers to maintain product integrity.
Adapt to Market Trends: Leverage emerging manufacturing capabilities and innovations in inhaler device technology to optimize product delivery.

FAQs

Who are the leading API suppliers for beclomethasone dipropionate used in TEXACORT?
Major API suppliers include Haldiya Pharmaceuticals (India), Mundipharma (Germany), Shanghai Desano (China), Aergon Pharma (Switzerland), and Cipla (India).
What regulatory standards ensure the quality of API suppliers for TEXACORT?
Suppliers must comply with GMP (Good Manufacturing Practice) and be certified under international agencies such as the FDA, EMA, or WHO prequalification programs.
How does regional manufacturing impact the supply chain of TEXACORT?
Regional manufacturing influences cost, quality, and regulatory compliance; Asia offers cost-effective APIs, Europe emphasizes high quality, and North America relies heavily on imports from abroad.
Are there risks associated with sourcing from Asian API manufacturers?
Yes, including variability in quality standards and regulatory differences; thorough audits and certifications mitigate these risks.
What future market shifts could influence TEXACORT supply chain dynamics?
Growth in biosimilars, regional demand increases, environmental sustainability initiatives, and evolving regulatory landscapes are key factors shaping future supply chains.

References

[1] Haldiya Pharmaceuticals, GMP Certification Details, 2023.
[2] Mundipharma Corporate Overview, Market Data, 2022.
[3] Shanghai Desano Pharmaceutical, Product Portfolio, 2023.
[4] Aergon Pharma, API Quality Standards, 2022.

Suppliers and packagers for TEXACORT

TEXACORT

Suppliers for the Pharmaceutical Drug: TEXACORT