Suppliers and packagers for PREVACID 24 HR

PREVACID 24 HR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Perrigo Pharma Intl	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327	NDA	L. Perrigo Company	0113-6002-01	1 BOTTLE in 1 CARTON (0113-6002-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2020-11-05
Perrigo Pharma Intl	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327	NDA	L. Perrigo Company	0113-6002-03	3 BOTTLE in 1 CARTON (0113-6002-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2020-11-05

Suppliers for the Pharmaceutical Drug: PREVACID 24 HR

Last updated: August 3, 2025

Introduction

Prevacid 24 HR, the brand name for lansoprazole, is a proton pump inhibitor widely used for treating gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome. Its global demand has driven diverse procurement channels, including original manufacturers, authorized distributors, and third-party suppliers. This report examines the key suppliers for Prevacid 24 HR, highlighting manufacturing companies, distribution practices, and the impact on supply chain stability, which are critical for stakeholders aiming to ensure consistent access and competitive sourcing.

Manufacturers of Prevacid 24 HR

The primary production of Prevacid 24 HR originates from a limited number of original manufacturers, notably Takeda Pharmaceutical Company, the patent holder and the initial supplier since its introduction in 1995. Takeda's expansive manufacturing facilities in Japan, the United States, and Europe enable large-scale production, adhering to stringent quality standards mandated by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In recent years, patent expiration in multiple markets has facilitated the entry of generic producers, expanding the supplier landscape. Notable generic manufacturers include:

• Mylan (now part of Viatris): A significant producer of lansoprazole generics, supplying numerous countries.
• Sandoz (a Novartis division): Offers generic lansoprazole with a focus on quality and affordability.
• Sun Pharmaceutical Industries: One of the top global generics producers, providing affordable alternatives in emerging markets.
• Dr. Reddy’s Laboratories: Supplying generic formulations of pre-existing drugs, including lansoprazole.
• Natco Pharma: An Indian pharmaceutical company manufacturing generic PPIs.

These manufacturers typically produce Prevacid 24 HR in capsule form, applying proprietary formulation techniques to deliver acid suppression over a 24-hour period.

Authorized Distributors and Supply Chain Partners

To ensure broad market reach, Takeda and generic manufacturers collaborate with authorized distribution networks. These include:

• Global Distributors: Companies like McKesson, Cardinal Health, and Owens & Minor operate as intermediaries, ensuring product availability across Pharmacies, hospitals, and clinics.
• Regional Distributors: Local pharma distributors in Latin America, Asia-Pacific, and Africa tailor supply chains to regional regulations and market demands.
• Online Pharmaceutical Markets: An increasing number of online pharmacy networks source Prevacid 24 HR through accredited suppliers, though with increased scrutiny regarding authenticity and regulatory compliance.

Authorization from Takeda or approved generic firms ensures distribution legitimacy and product quality. These authorized distribution channels mitigate risks of counterfeit products entering the supply chain.

Impact of Patent Expiry and Generic Competition

Patent expiry dramatically expanded the supplier base, fostering competition that benefits healthcare providers through reduced costs and improved access. Since the first patent expiration around 2012 in the United States, multiple generics have entered the market, solidifying a diverse supplier ecosystem.

This proliferation influences supply stability, as reliance on a single supplier diminishes, but also introduces variability in supply chains. Potential risks include manufacturing disruptions, geopolitical factors, and regulatory delays affecting certain suppliers.

Regulatory and Quality Considerations

All suppliers must comply with the regulatory standards pertinent to their regions. Takeda's manufacturing facilities operate under Good Manufacturing Practices (GMP) compliant with FDA and EMA guidelines, ensuring product consistency and safety. Generic manufacturers are required to submit Abbreviated New Drug Applications (ANDAs) demonstrating bioequivalence and manufacturing efficacy.

Certifications and audits of manufacturing plants by regulatory bodies influence the credibility and reliability of suppliers. Pharmacovigilance practices and product traceability are critical to uphold quality and manage supply risks.

Supply Chain Challenges and Opportunities

The pharmaceutical supply chain for Prevacid 24 HR faces numerous challenges:

• Global Demand Fluctuations: Adjustments in prescribing trends or patent litigation outcomes influence supplier production volumes.
• Regulatory Variability: Different countries' approval processes can delay market entry for new suppliers or generic versions.
• Manufacturing Bottlenecks: Capacity constraints or quality control issues can disrupt supplies, especially amid increased demand or during global crises such as COVID-19.

Conversely, strategic partnerships, increasing manufacturing capacity, and regional production facilities offer opportunities for steadier supply of Prevacid 24 HR:

• Local manufacturing in emerging markets reduces lead times and logistical complexities.
• Collaborations with contract manufacturing organizations (CMOs) allow for flexible scaling of production.

Conclusion

The landscape of Prevacid 24 HR suppliers comprises a carefully balanced mix of original innovators, multiple generic manufacturers, and a robust distribution ecosystem. The expiration of patent protections has democratized supply sources, leading to competitive pricing and improved availability globally. However, supply chain stability hinges on strict quality controls, regulatory compliance, and proactive capacity management by suppliers.

Key Takeaways

• Takeda remains the primary original producer, with numerous generic manufacturers filling the post-patent market.
• A diversified supplier base reduces dependence on single sources, enhancing supply resilience.
• Regulatory compliance and quality assurance are critical to maintaining supply chain integrity.
• Global demand fluctuations and manufacturing disruptions pose ongoing risks requiring strategic mitigation.
• Emerging regional manufacturing and CMO partnerships present avenues for ensuring uninterrupted supply.

FAQs

1. Who are the leading suppliers of Prevacid 24 HR globally?
Takeda Pharmaceutical is the original patent holder and primary supplier. Post-patent, major generic producers include Viatris (Mylan), Sandoz, Sun Pharma, Dr. Reddy’s, and Natco Pharma, among others.

2. How does patent expiry affect the supplier landscape for Prevacid 24 HR?
Patent expiry enables multiple generic manufacturers to produce bioequivalent formulations, leading to increased competition, more supplier options, and generally lower prices, but also necessitates robust quality oversight.

3. What are the key factors in selecting a Prevacid 24 HR supplier?
Regulatory compliance, manufacturing quality standards (GMP), supply reliability, pricing, and accreditation by relevant authorities are primary considerations.

4. Are there risks associated with sourcing Prevacid 24 HR from multiple suppliers?
Yes. Variability in manufacturing quality, regulatory differences, and supply chain complexities can introduce risks. Proper vetting and ongoing monitoring mitigate these issues.

5. How can healthcare providers ensure the authenticity and quality of Prevacid 24 HR?
Procure through authorized distributors, verify supplier certifications, and adhere to regulatory guidelines to prevent counterfeit products and ensure high-quality standards.

References

1. Takeda Pharmaceutical Company. (2022). Prevacid (lansoprazole) Product Information.
2. U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
3. Generic Pharmaceutical Association. (2022). Market Dynamics of Proton Pump Inhibitors.
4. European Medicines Agency. (2022). Marketing Authorization for Lansoprazole.
5. GlobalData Healthcare. (2023). Pharmaceutical Industry Insights — Proton Pump Inhibitors Sector.