PRED MILD: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	PRED MILD	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017100	NDA	Allergan, Inc.	11980-174-05	1 BOTTLE, DROPPER in 1 CARTON (11980-174-05) / 5 mL in 1 BOTTLE, DROPPER	1972-12-01
Abbvie	PRED MILD	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017100	NDA	Allergan, Inc.	11980-174-10	1 BOTTLE, DROPPER in 1 CARTON (11980-174-10) / 10 mL in 1 BOTTLE, DROPPER	1972-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

PRED MILD is a pharmaceutical product designated primarily for allergic and inflammatory conditions. As a corticosteroid therapy, it encompasses active ingredients aimed at mitigating immune responses associated with allergies, asthma, and other inflammatory disorders. The procurement landscape for PRED MILD involves an intricate network of manufacturers, suppliers, and distributors, reflecting the criticality of quality, compliance, and supply chain resilience in the pharmaceutical ecosystem.

This report explores the key suppliers involved in the manufacturing, formulation, and distribution of PRED MILD, with a focus on the global and regional landscape, typical sourcing models, and strategic considerations for stakeholders.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of PRED MILD is a corticosteroid API, most notably prednisolone or its derivatives. Securing high-quality API sources is crucial for efficacy, safety compliance, and regulatory approval.

Major API Manufacturers

Sun Pharmaceutical Industries Ltd.
Among leading producers globally, Sun Pharma supplies prednisolone API to various generic and branded formulations. They maintain cGMP compliance, ensuring high-quality standards aligning with US FDA and EMA regulations.
Dr. Reddy’s Laboratories
A prominent Indian pharmaceutical manufacturer, Dr. Reddy’s produces prednisolone API for both domestic and export markets. Their manufacturing facilities are WHO-GMP certified, ensuring regulatory adherence.
Alphapharm (AstraZeneca)
AstraZeneca’s API manufacturing units supply prednisolone for their branded products and collaborations. Their rigorous quality controls demonstrate reliability.
Cipla Limited
Cipla manufactures prednisolone API, primarily serving Indian markets but with expanding global distribution. Their API manufacturing facilities adhere to international standards.
Mann Healthcare Group
A Chinese API manufacturer with growing prominence, Mann Healthcare supplies prednisolone API to emerging markets, leveraging cost efficiencies.

Regional API Producers
Other regional API providers, such as Hetero Labs (India), Mylan (now part of Viatris), and Teva Pharmaceutical Industries, also contribute to the supply chain, often catering to localized markets with more flexible procurement options.

Formulation and Finished Product Suppliers

After sourcing the API, pharmaceutical companies require reliable formulation partners for manufacturing PRED MILD tablets or suspensions.

Key Formulation Contract Manufacturers

Aurobindo Pharma
Known for contract manufacturing, Aurobindo supplies finished formulations, including corticosteroid-based products, with robust quality assurance in compliance with international standards.
Xintec Pharma
Specializing in capsule and tablet formulations, Xintec provides manufacturing capacity for PRED MILD, especially in Asian markets.
Neuland Laboratories
Apart from API manufacturing, Neuland has expanded into formulation services, offering a vertically integrated approach.
Vivimed Labs
Focuses on various dosage forms, including tablets and suspensions, serving both domestic and export markets.

Distribution and Supply Chain Infrastructure

Supply chain integrity is vital for ensuring PRED MILD’s availability across regions. Major pharmaceutical distributors and wholesalers play pivotal roles.

Global Distributors & Wholesalers

McKesson Corporation
Cencora (formerly AmerisourceBergen)
Cardinal Health
Linmark Group

Below these global players, regional distributors offer penetration into local markets, especially in emerging economies.

Regional Distributors

India: Lloyds Pharma, Micro Labs, and Sun Pharmaceutical Wholesale Divisions
Africa & Middle East: Globalpharma, Neopharma
Latin America: Laboratorios PiSA, Farmacias del Ahorro

Regulatory and Quality Considerations

Suppliers for PRED MILD must demonstrate compliance with stringent quality principles, including cGMP, ISO standards, and adherence to the WHO prequalification where applicable. The pharmaceutical supply chain operates under strict regulatory oversight, emphasizing traceability and consistency.

API suppliers often validate their APIs through batch testing, stability studies, and regulatory submissions, which are critical for downstream formulation development and market approval.

Supply Chain Risks and Opportunities

The reliance on suppliers from regions with variable regulatory rigor exposes manufacturers to risks such as supply disruptions, regulatory delays, or quality lapses. Diversifying supplier bases and establishing long-term contracts can mitigate these risks.

Emerging markets accommodate local manufacturing and API production, reducing dependency on imports and lowering costs. Strategic alliances, licensing agreements, and joint ventures are common for ensuring supply continuity.

Strategic Considerations for Stakeholders

Quality Assurance: Prioritize suppliers with proven regulatory compliance and validated manufacturing processes to ensure drug safety and efficacy.
Cost Efficiency: Balance between high-quality suppliers and cost considerations. Indian and Chinese manufacturers often offer competitive pricing but require robust quality validation.
Supply Chain Resilience: Build diversified supplier portfolios to mitigate geopolitical, logistical, or regulatory disruptions.
Regulatory Monitoring: Regularly review each supplier’s compliance status and participating regulatory approvals to maintain market access.

Conclusion

The supply landscape for PRED MILD encompasses a global network of API manufacturers, formulation specialists, and distributors. Indian firms such as Sun Pharma, Dr. Reddy’s, and Cipla serve as primary API sources, supported by regional players in China and other emerging markets. Contract manufacturing organizations play significant roles in delivering finished dosage forms, ensuring quality and compliance.

Given the importance of quality, regulatory adherence, and supply chain stability, stakeholders must adopt a strategic approach to supplier selection, diversification, and ongoing compliance monitoring to sustain reliable provision of PRED MILD.

Key Takeaways

Diverse API sourcing is vital: Major Indian manufacturers dominate API supply, complemented by Chinese firms and others from emerging markets.
Quality and compliance are non-negotiable: All suppliers must demonstrate adherence to international cGMP standards and regulatory approvals.
Supply chain resilience impacts market stability: Diversification of suppliers and geographic spread mitigate risks of disruption.
Regional formulation partners enhance agility: Contract manufacturers facilitate tailored production to meet regional demands.
Regulatory vigilance is crucial: Continuous monitoring ensures supplier compliance and maintains market access.

FAQs

1. Who are the leading API suppliers for PRED MILD?
Major API providers include Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, Cipla, and Mann Healthcare Group, primarily based in India and China.

2. How do suppliers ensure high-quality API production?
By adhering to cGMP standards, undergoing regular audits, and maintaining comprehensive quality control protocols, these manufacturers ensure API quality.

3. Can regional manufacturers impact the global supply of PRED MILD?
Yes, regional manufacturers can provide flexible, cost-effective options, especially in local markets, but scaling globally requires establishing trust through regulatory compliance.

4. What are risks associated with reliance on AP suppliers from emerging markets?
Potential risks include regulatory delays, quality variability, and supply disruptions due to geopolitical or logistical issues.

5. How can manufacturers mitigate supply chain risks for PRED MILD?
By diversifying supplier sources, establishing long-term partnerships, and maintaining compliance oversight, manufacturers can safeguard supply continuity.

References

[1] Indian Pharmaceutical Alliance. API Manufacturing Standards.
[2] U.S. FDA. Guidelines for Good Manufacturing Practices (GMP).
[3] World Health Organization. Prequalification of Medicines Program.
[4] Industry Reports. Global API Market Trends.
[5] Company Websites and Regulatory Filings.

Suppliers and packagers for PRED MILD

PRED MILD

Suppliers for the Pharmaceutical Drug: PRED MILD