BETAMETHASONE DIPROPIONATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Inc	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	078930	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-290-17	15 g in 1 TUBE (68462-290-17)	2008-09-23
Glenmark Pharms Inc	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	078930	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-290-52	50 g in 1 TUBE (68462-290-52)	2008-09-23
Padagis Israel	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076592	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-376-32	1 TUBE in 1 CARTON (45802-376-32) / 50 g in 1 TUBE	2006-09-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Betamethasone Dipropionate is a potent topical corticosteroid extensively used to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis. Its efficacy hinges on its anti-inflammatory, antipruritic, and vasoconstrictive properties. Given its widespread application, a robust supply chain comprising reputable manufacturers and suppliers is crucial to ensuring consistent availability, regulatory compliance, and quality assurance. This article provides an in-depth analysis of key suppliers of Betamethasone Dipropionate, identifying leading manufacturers, geographic distribution, regulatory considerations, and market dynamics.

Overview of Betamethasone Dipropionate

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid with high potency. It is typically formulated as a cream, ointment, or gel. The drug's molecular structure and pharmacological profile necessitate stringent manufacturing protocols to maintain its efficacy and safety [1].

The global demand for Betamethasone Dipropionate remains steady, driven by dermatological needs and evolving treatment protocols. As such, the supply chain involves multiple stakeholders, from chemical producers to finished pharmaceutical manufacturers.

Major Suppliers and Manufacturers

1. Sandoz (Novartis Division)

Sandoz, a Novartis division, is a prominent manufacturer of Betamethasone Dipropionate, supplying both active pharmaceutical ingredients (APIs) and finished dosage forms. The company offers high-quality products adhering to Good Manufacturing Practices (GMP) and obtains regulatory approvals across major markets.

Manufacturing Capacity & Locations: Sandoz operates facilities in Europe and the United States, with advanced infrastructure supporting large-scale production.
Regulatory Compliance: Sandoz’s Betamethasone Dipropionate products comply with US FDA, EMA, and other regional standards.
Market Presence: Sandoz’s products are widely distributed globally, making it a key supplier especially in North America and Europe.

2. Gufic Biosciences Ltd.

Gufic Biosciences is an Indian pharmaceutical company specializing in steroidal APIs, including Betamethasone Dipropionate. It caters to both domestic markets and exports.

Manufacturing Capabilities: Gufic’s facilities adhere to WHO GMP standards, with a focus on affordability and quality.
Distribution: Strong presence across Asia, Africa, and parts of Latin America, with an expanding footprint in regulated markets.

3. Catalent, Inc.

Catalent is an American contract development and manufacturing organization (CDMO) providing tailored solutions for API synthesis, including corticosteroids like Betamethasone Dipropionate.

Expertise: Known for high-quality production processes, ensuring consistency and compliance.
Client Base: Serves both branded and generic pharmaceutical companies, emphasizing scalable solutions.

4. Mylan (now part of Viatris)

Mylan, now integrated into Viatris, historically supplied Betamethasone Dipropionate API and finished formulations.

Manufacturing Locations: Facilities across North America, Europe, and Asia.
Regulatory Standing: Known for adhering to stringent global regulatory standards.

5. Other Notable Suppliers

Athenex and Hospira (a Pfizer subsidiary) also manufacture corticosteroid APIs, including Betamethasone Dipropionate, focusing on quality and supply reliability.
Several Chinese and Indian API manufacturers, such as Sun Pharmaceutical Industries and LGM Pharma, provide Betamethasone Dipropionate at competitive prices, predominantly serving generic markets.

Geographic Distribution and Market Dynamics

The supply landscape for Betamethasone Dipropionate is geographically diverse, with key production hubs in North America, Europe, India, and China:

North America and Europe: Dominated by multinational corporations like Novartis, Catalent, and Mylan, emphasizing regulatory compliance, quality assurance, and supply stability.
Asia-Pacific: Characterized by high-volume, cost-effective manufacturing primarily led by Indian and Chinese API producers, catering to both domestic and export markets.

The globalization of pharmaceutical manufacturing has increased competition, prompting differential pricing and supply-chain diversification. Regulatory harmonization efforts, such as those by the EMA and US FDA, underpin the trust in suppliers from these regions.

Regulatory and Quality Considerations

Ensuring regulatory compliance is critical for Betamethasone Dipropionate suppliers, particularly as the drug falls under corticosteroid controls due to potential misuse and side effects if improperly produced. Suppliers must demonstrate adherence to:

Good Manufacturing Practices (GMP).
ISO Certifications.
Compliance with regional regulatory agencies: US FDA (Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan), and others.

Furthermore, suppliers with GMP certifications and proven track records in quality control minimize risks related to adulteration, contamination, and efficacy issues.

Market Entry and Supplier Selection Strategies

For pharmaceutical companies seeking new Betamethasone Dipropionate suppliers, key considerations include:

Regulatory compliance: Ensuring the manufacturer meets regional standards.
Quality assurance: Verifying GMP certifications and quality control protocols.
Supply stability: Assessing manufacturing capacity, lead times, and contingency planning.
Cost competitiveness: Balancing quality with price considerations, especially in high-volume productions.
Reputation and track record: Evaluating supplier history, regulatory audits, and customer feedback.

Establishing long-term supply relationships often involves qualification processes, audits, and continuous monitoring.

Future Outlook

The Betamethasone Dipropionate market is expected to remain stable, driven by ongoing dermatological treatment needs. However, increasing emphasis on sustainable manufacturing, regulatory compliance, and supply chain resilience will influence supplier dynamics. The emergence of regional manufacturing hubs, especially in Asia, forecasted to meet escalating global demand.

Advances in synthetic chemistry and process optimization may also lead to improved production efficiencies, reducing costs and environmental impact, thereby influencing supplier competitiveness.

Key Takeaways

Leading Suppliers: Sandoz, Gufic Biosciences, Catalent, Viatris (Mylan), and emerging Asian API producers are primary sources.
Regional Dynamics: North America and Europe dominate regulatory standards; Asia offers cost advantages with high-volume production.
Quality and Compliance: Regulatory adherence and GMP certification are non-negotiable for supplier qualification.
Market Trends: Diversification of suppliers and regional manufacturing capabilities enhance supply stability and cost competitiveness.
Strategic Sourcing: Pharma companies should rigorously evaluate supplier capacity, compliance, and reputation to mitigate risks.

FAQs

1. What are the primary regions producing Betamethasone Dipropionate?
North America, Europe, India, and China are the main production hubs, with North America and Europe focusing on quality and regulation, while India and China offer cost-effective manufacturing.

2. How can I verify the quality of a Betamethasone Dipropionate supplier?
By reviewing GMP certifications, regulatory compliance records, conducting supplier audits, and analyzing quality assurance protocols.

3. Are there any regulatory concerns associated with Asian suppliers?
While many Asian suppliers adhere to international standards, due diligence is necessary to verify GMP certification and compliance with regional regulations to mitigate risks.

4. What factors influence the choice of a Betamethasone Dipropionate supplier?
Regulatory adherence, quality assurance, manufacturing capacity, supply stability, cost, and supplier reputation.

5. Is the Betamethasone Dipropionate market expected to grow?
Yes, driven by ongoing dermatological healthcare needs and potential new formulations, the market is projected to remain stable with growth opportunities, particularly through regional production enhancements.

References

[1] World Health Organization. (2020). Guidelines for the manufacture of corticosteroids.
[2] Novartis. (2022). Sandoz product information on Betamethasone Dipropionate.
[3] Gufic Biosciences Ltd. Official Website.
[4] Catalent Inc. Corporate Overview.
[5] Viatris. (2021). Product portfolio and manufacturing capabilities.

Disclaimer: The information provided is for informational purposes only and should not substitute for professional procurement, regulatory, or pharmaceutical consultancy.

Suppliers and packagers for generic pharmaceutical drug: BETAMETHASONE DIPROPIONATE