Suppliers and packagers for generic pharmaceutical drug: DEFLAZACORT

DEFLAZACORT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tris Pharma Inc	DEFLAZACORT	deflazacort	SUSPENSION;ORAL	217813	ANDA	Cranbury Pharmaceuticals, LLC	27808-249-01	13 mL in 1 BOTTLE (27808-249-01)	2024-05-01
Zydus Lifesciences	DEFLAZACORT	deflazacort	SUSPENSION;ORAL	220042	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-2007-3	1 BOTTLE in 1 CARTON (70710-2007-3) / 13 mL in 1 BOTTLE	2025-10-23
Zydus Lifesciences	DEFLAZACORT	deflazacort	SUSPENSION;ORAL	220042	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-2131-3	1 BOTTLE in 1 CARTON (70710-2131-3) / 13 mL in 1 BOTTLE	2025-11-20
Zydus Lifesciences	DEFLAZACORT	deflazacort	SUSPENSION;ORAL	220042	ANDA	Doppel Farmaceutici S.r.l.	81806-200-73	1 BOTTLE in 1 CARTON (81806-200-73) / 13 mL in 1 BOTTLE	2025-10-23
Ptc Therap	EMFLAZA	deflazacort	SUSPENSION;ORAL	208685	NDA	PTC Therapeutics, Inc.	52856-505-22	13 mL in 1 BOTTLE (52856-505-22)	2018-09-10

Suppliers for the Pharmaceutical Drug: Deflazacort

Last updated: July 29, 2025

Introduction

Deflazacort is a synthetic corticosteroid widely used to treat a range of inflammatory, autoimmune, and muscular disorders, including Duchenne muscular dystrophy (DMD). Its efficacy in reducing inflammation and immune response has made it a vital medication, especially among pediatric populations. As demand for deflazacort rises, understanding its supply chain dynamics, key suppliers, and manufacturing landscape has become crucial for pharmaceutical companies, healthcare providers, and policymakers.

This comprehensive analysis examines the current landscape of deflazacort suppliers, including primary manufacturing companies, generic producers, and distribution channels. Emphasis is placed on regulatory environments, patent status, regional availability, and market trends to inform strategic decision-making.

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Manufacturers and Key Suppliers of Deflazacort

Original Brand Manufacturers

The patent for deflazacort was initially held by Mitsubishi Tanabe Pharma Corporation, a major Japanese pharmaceutical company that pioneered its development (originally marketed as "Emflaza" for Duchenne muscular dystrophy). Mitsubishi Tanabe remains a key player in the production and distribution of deflazacort, especially in Japan and some Asian markets. The company's manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality standards.

Generic Manufacturers

Following patent expiration or licensing agreements, several generic pharmaceutical companies entered the deflazacort market, significantly expanding global supply options. Notable manufacturers include:

• Cipla Limited (India): A leading generic producer, Cipla supplies deflazacort in various dosages, primarily targeting the Indian and emerging markets. Cipla's extensive API (Active Pharmaceutical Ingredient) production capabilities enable large-scale manufacturing.

• Biocon Limited: An Indian biopharmaceutical firm with a substantial generics portfolio, including deflazacort. Biocon benefits from robust API synthesis and cost-effective manufacturing.

• TEVA Pharmaceutical Industries Ltd. (Israel): TEVA has been involved in producing and marketing corticosteroids, including deflazacort for various regional markets, pending licensing agreements.

• Zhejiang Huayuan Pharmaceutical Co., Ltd. (China): A regional supplier that produces generic corticosteroids, including deflazacort, primarily serving the Chinese and Southeast Asian markets.

• Hetero Labs Ltd. (India): Hetero is known for its API manufacturing and finished dosage forms, supplying deflazacort to multiple markets through licensing arrangements.

API Suppliers and Contract Manufacturers

API sourcing is pivotal, especially for large pharmaceutical corporations. Major API suppliers of deflazacort include:

• Sinochem Lunan (China): Known for their chemical synthesis expertise, Sinochem supplies pharmaceutical intermediates and APIs, including corticosteroids.

• Hubei Huzhicheng Pharmaceutical Co., Ltd.: Specializes in steroid hormone APIs, including deflazacort, primarily serving the Chinese market.

• Erisynth Labs and Ajanta Pharma: Contract manufacturers that may produce deflazacort APIs under licensing agreements.

Regional Supply Dynamics

• Asia: The majority of API manufacturing and generic production occurs in India and China due to lower production costs and established chemical synthesis infrastructure. These regions dominate the affordable supply of generic deflazacort.

• Europe: Limited direct manufacturing, with some licensing agreements allowing European-based companies to distribute generic versions.

• North America: The U.S. market primarily relies on licensed imports and original branded versions due to patent protections and regulatory barriers.

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Regulatory Landscape and Market Impact

The regulatory frameworks influence supplier roles significantly. In regions where patents have expired, generic manufacturers have expanded production, increasing supply diversity and competitiveness. Conversely, in markets with active patent protections, supply is limited to original developers or licensed generics.

For example, Mitsubishi Tanabe’s key patent protections in certain jurisdictions have limited generic entry until their expiration. Once patents expire, manufacturers like Cipla and Hetero gain market access, increasing overall supply and impacting pricing.

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Supply Chain Challenges and Opportunities

Challenges

• Patent Protection and Litigation: Patent disputes in various jurisdictions can hinder generic entry, leading to supply shortages or higher prices.

• Regulatory Barriers: Obtaining approvals from agencies like the FDA, EMA, or PMDA involves rigorous testing, which can delay market entry for new suppliers.

• API Quality and Consistency: Variability in API quality among regional suppliers affects the overall drug safety and efficacy perception.

• Market Concentration: Dependence on a few key suppliers in certain regions may pose risks of supply disruption.

Opportunities

• Emerging Market Entry: Countries with less stringent patent enforcement provide opportunities for new suppliers to introduce affordable generic deflazacort.

• Contract Manufacturing Agreements (CMAs): Pharmaceutical companies can leverage CMAs to diversify supply sources, reduce costs, and secure continuous supply.

• Vertical Integration: Manufacturers investing in API synthesis and formulation can better control quality, costs, and supply timelines.

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Market Trends and Future Outlook

• Increased Generic Penetration: The expiration of patents, particularly in North America and Europe, is expected to boost generic production, significantly lowering costs and improving access.

• Regional Expansion: Suppliers from India and China are expanding their presence into regulated markets, facilitated by increased regulatory approvals and higher quality standards.

• Emerging Biosynthetic Methods: Advances in bioengineering may facilitate alternative pathways for deflazacort production, potentially expanding supply options.

• Supply Chain Resilience: The COVID-19 pandemic underscored the importance of diversified manufacturing bases. Companies are now investing in multiple regional facilities to mitigate disruptions.

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Conclusion

The landscape for deflazacort suppliers reflects a dynamic interplay of patent protections, regional manufacturing capacities, and regulatory frameworks. Original developers like Mitsubishi Tanabe hold the primary market share in advanced markets through their patented formulations. Meanwhile, a growing roster of generic manufacturers—led by Indian firms such as Cipla, Hetero, and Biocon—are expanding global supply, driven by patent expirations and cost advantages.

Regional API producers in China and India serve as backbone suppliers, providing affordable raw materials that support extensive generic manufacturing. Regulatory advancements have facilitated entry for multiple suppliers, thus enhancing supply security and affordability. Nonetheless, supply chain risks remain due to patent litigation, quality variability, and geopolitical factors.

Strategic suppliers should prioritize regulatory compliance and quality assurance to capitalize on market growth. Investors and healthcare stakeholders should monitor patent timelines, regulatory approvals, and regional market expansions to optimize sourcing and portfolio management.

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Key Takeaways

• Diversification is critical: Multiple regional suppliers and generic manufacturers mitigate supply risks and foster competitive pricing.

• Patent expiry drives supply expansion: Market dynamics are poised to shift as key patents expire, opening opportunities for new entrants.

• Regulatory compliance remains paramount: Ensuring API and finished product quality is essential for market acceptance, especially in stringent regulatory regions.

• Emerging markets offer growth prospects: India and China dominate API production, with increasing approvals in regulated markets.

• Supply chain resilience enhances stability: Developing multi-source manufacturing bases reduces vulnerability to geopolitical and pandemic-related disruptions.

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FAQs

1. Who are the leading global suppliers of deflazacort?
Leading suppliers include Mitsubishi Tanabe Pharma (original patent holder), Cipla, Hetero, Biocon, and Zhejiang Huayuan Pharma, the primary producers of generic versions.

2. Are there any patent restrictions affecting deflazacort supply?
Yes. Patents held by Mitsubishi Tanabe initially restricted generic competition; however, these patents have expired or are nearing expiration in several markets, facilitating increased generic production.

3. What regions predominantly manufacture deflazacort APIs?
India and China dominate API manufacturing due to cost advantages and established chemical synthesis capabilities.

4. How does regulatory approval impact deflazacort suppliers?
Regulatory approval ensures API and finished dosage form quality, enabling manufacturers to access major markets. Complex approval processes can delay supplier entry or expansion.

5. What future supply trends are expected for deflazacort?
Increased generic penetration post-patent expiry, expanding API production in Asia, and potential biosynthetic advancements are expected to ensure continued supply growth and market resilience.

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Sources:

[1] Mitsubishi Tanabe Pharma Corporation. (n.d.). Product Information.
[2] Cipla Ltd. Annual Reports and Product Catalog.
[3] Hetero Labs Ltd. API Portfolio Details.
[4] U.S. Food and Drug Administration (FDA). Regulatory approvals for corticosteroids.
[5] Market Research Future. "Global Deflazacort Market Analysis," 2022.