METHYLPREDNISOLONE ACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DEPO-MEDROL	methylprednisolone acetate	INJECTABLE;INJECTION	011757	NDA	Pharmacia & Upjohn Company LLC	0009-0274-01	1 VIAL, MULTI-DOSE in 1 CARTON (0009-0274-01) / 5 mL in 1 VIAL, MULTI-DOSE	1959-05-28
Pfizer	DEPO-MEDROL	methylprednisolone acetate	INJECTABLE;INJECTION	011757	NDA	Pharmacia & Upjohn Company LLC	0009-0280-02	1 VIAL, MULTI-DOSE in 1 CARTON (0009-0280-02) / 5 mL in 1 VIAL, MULTI-DOSE	1959-05-28
Pfizer	DEPO-MEDROL	methylprednisolone acetate	INJECTABLE;INJECTION	011757	NDA	Pharmacia & Upjohn Company LLC	0009-0280-03	10 mL in 1 VIAL, MULTI-DOSE (0009-0280-03)	1959-05-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Methylprednisolone acetate, a corticosteroid used in various inflammatory and autoimmune conditions, remains a critical compound for both clinical applications and pharmaceutical manufacturing. As a long-acting formulation of methylprednisolone, the acetate ester provides sustained release and increased stability. Given its widespread use, identifying reputable suppliers for methylprednisolone acetate is vital for pharmaceutical companies, healthcare providers, and compounding pharmacies. This report offers a comprehensive overview of key manufacturers, distributors, and sourcing considerations for methylprednisolone acetate, underscoring their market presence, compliance standards, and supply capabilities.

Global Market Overview and Demand Dynamics

The demand for methylprednisolone acetate is driven primarily by its application in treating conditions such as allergic reactions, rheumatoid arthritis, and severe inflammatory states. The pharmaceutical industry's need for high-quality, reliable sources aligns with increasing regulatory scrutiny and the necessity for Good Manufacturing Practices (GMP) compliance. The global market for corticosteroids, including methylprednisolone derivatives, is projected to grow steadily, with Asia-Pacific emerging as a significant manufacturing hub due to cost-effective production and expanding healthcare infrastructure [1].

Leading Suppliers of Methylprednisolone Acetate

1. Pfizer Inc.

Overview:
Pfizer remains a dominant player in corticosteroid manufacturing, leveraging its extensive R&D infrastructure. The company produces methylprednisolone acetate primarily for institutional and bulk pharmaceutical use. Pfizer's products are known for stringent quality control, compliance with international standards, and global distribution networks.

Supply Capabilities:

Robust manufacturing facilities adhering to cGMP standards.
Multinational distribution channels ensuring worldwide availability.
Extensive product portfolio supporting batch consistency and high purity levels.

Regulatory and Compliance:
Pfizer’s methylprednisolone acetate products are approved by authorities such as the U.S. FDA and EMA, ensuring regulatory compliance for international markets [2].

2. Sandoz (Novartis Group)

Overview:
Sandoz specializes in generic pharmaceuticals, including corticosteroid formulations like methylprednisolone acetate. Their focus on cost-efficient production and high-volume supply makes them a preferred supplier in both developed and emerging markets.

Supply Capabilities:

Large-scale manufacturing facilities with a focus on sterile and non-sterile injectables.
Product standardization compliant with pharmacopoeial standards (USP, EP, BP).
Proven track record of supply continuity and quality assurance.

Regulatory Support:
Sandoz’s methylprednisolone acetate products are approved across multiple jurisdictions, supported by comprehensive regulatory filings [3].

3. Teva Pharmaceutical Industries Ltd.

Overview:
Teva, a leading generic pharmaceutical manufacturer, offers methylprednisolone acetate in various formulations. Their global footprint and expertise in corticosteroid production position them as a reliable source.

Supply Capabilities:

Extensive manufacturing capacity aligned with GMP.
Focus on affordable generics without compromising quality.
Reliable logistics networks for timely supply.

Compliance:
Teva’s products conform to international standards, with approvals from agencies such as the FDA, MHRA, and TGA [4].

4. Cipla Limited

Overview:
An Indian pharmaceutical giant, Cipla produces methylprednisolone acetate primarily for the Asian, African, and Middle Eastern markets. Their emphasis on affordable medicine aligns with regional demand.

Supply Capabilities:

Multiple manufacturing units with WHO-GMP certification.
Competitive pricing structure catering to emerging markets.
Ability to scale production rapidly based on demand.

Regulatory Credentials:
Cipla maintains compliance with local and international standards, with some products approved by the US FDA and EMA [5].

5. Sun Pharmaceutical Industries Ltd.

Overview:
Sun Pharma offers methylprednisolone acetate as part of their corticosteroid portfolio, emphasizing high-quality manufacturing and global reach.

Supply Capabilities:

State-of-the-art manufacturing facilities with certifications including FDA, EMA, and WHO-GMP.
Wide distribution channels ensuring supply chain resilience.
Focus on high-purity injections and sterile formulations.

Regulatory and Quality Assurance:
Sun Pharma’s products are compliant with pharmacopoeial standards and backed by rigorous quality testing [6].

Emerging and Contract Manufacturers

Beyond major names, increasing reliance on Contract Manufacturing Organizations (CMOs) offers additional sourcing options. These firms often provide customization, scale flexibility, and regulatory support:

Hikma Pharmaceuticals: Specialized in sterile injectables, including corticosteroids.
Richwood Pharmaceutical: Known for high-quality active pharmaceutical ingredients (APIs).
Zhejiang NHU Co.,Ltd: Chinese API producer with significant capacity for corticosteroids.

Note: When partnering with CMOs, due diligence involves confirming GMP certifications, API purity levels, and regulatory approvals in target markets.

Supply Chain Considerations

Quality and Regulatory Compliance:
Prioritize suppliers with established GMP protocols, validated manufacturing processes, and approvals from major health authorities (FDA, EMA, TGA). Ensuring API bioequivalence and high purity mitigates risks in formulation and patient safety.

Pricing and Cost-Effectiveness:
Regional manufacturing hubs offer cheaper options, but compliance and quality should take precedence over cost. Long-term contracts may secure favorable pricing and supply stability.

Lead Times and Logistics:
Global logistics networks influence sourcing decisions; suppliers with localized manufacturing and extensive distribution channels facilitate faster delivery timelines.

Regulatory Landscape and Import/Export Regulations

Compliance with international regulations essential for sourcing methylprednisolone acetate involves navigating import-export controls, licensing, and documentation requirements. Suppliers certified under ISO, cGMP, and pharmacopoeial standards streamline the regulatory process for pharmaceutical companies.

Conclusion

Securing reliable suppliers for methylprednisolone acetate requires meticulous evaluation of manufacturing quality, regulatory adherence, supply stability, and cost implications. Major pharmaceutical companies like Pfizer, Sandoz, Teva, Cipla, and Sun Pharma represent preferred sources in the global market. Emerging API manufacturers and CMOs expand the options, particularly in Asia-Pacific regions. Ensuring adherence to regulatory standards and quality certifications remains paramount for procurement success.

Key Takeaways

Supplier Selection: Prioritize suppliers with GMP certification, regulatory approvals, and proven manufacturing capabilities.
Market Dynamics: The global corticosteroid market is expanding, with Asia-Pacific emerging as a key manufacturing hub.
Quality Assurance: High purity and compliance with pharmacopoeial standards are critical to minimize safety and efficacy risks.
Supply Chain Resilience: Diversify sourcing channels to mitigate geopolitical or logistical disruptions.
Regulatory Strategy: Maintain up-to-date knowledge of import-export policies and documentation standards to ensure smooth procurement.

FAQs

1. What are the leading global manufacturers of methylprednisolone acetate?
Pfizer, Sandoz (Novartis), Teva, Cipla, and Sun Pharma are among the top global suppliers providing high-quality methylprednisolone acetate, each with extensive GMP-certified manufacturing facilities.

2. How do regional regulations influence sourcing decisions?
Regulatory frameworks affect approval, import licenses, and quality standards; sourcing from suppliers compliant with regional authorities (like FDA for the US, EMA for Europe, and TGA for Australia) ensures smoother market entry and compliance.

3. Are there differences in API quality between branded and generic suppliers?
Reputable generic API manufacturers such as Sandoz, Teva, and Cipla adhere to strict GMP standards, ensuring comparable bioavailability and purity to branded versions, provided proper quality checks are in place.

4. What factors should companies consider when partnering with CMOs for methylprednisolone acetate?
Assess GMP certification, manufacturing capacity, quality control protocols, past compliance history, and regulatory approvals specific to the target markets.

5. How does global supply chain disruption impact methylprednisolone acetate procurement?
Disruptions can cause delays, price fluctuations, and shortages. Diversifying suppliers, establishing local manufacturing partnerships, and maintaining safety stocks mitigate these risks.

References

[1] MarketsandMarkets. Corticosteroids Market by Type, Application, and Region. 2022.
[2] Pfizer Annual Report 2022.
[3] Sandoz Product Portfolio. 2023.
[4] Teva Annual Report 2022.
[5] Cipla Official Website. 2023.
[6] Sun Pharmaceutical Industries Ltd. Annual Report 2022.

Suppliers and packagers for generic pharmaceutical drug: METHYLPREDNISOLONE ACETATE