Share This Page
Suppliers and packagers for ESOMEPRAZOLE STRONTIUM
✉ Email this page to a colleague
ESOMEPRAZOLE STRONTIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Belcher | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | NDA | R2 Pharma, LLC | 70849-200-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30) | 2016-09-15 |
| Belcher | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | NDA | R2 Pharma, LLC | 70849-400-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-400-30) | 2016-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Esomeprazole Strontium
Introduction
Esomeprazole strontium is an emerging proton pump inhibitor (PPI) marketed primarily as a treatment for gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and erosive esophagitis. As a derivative of esomeprazole, its unique chemical formulation offers potential advantages, including enhanced stability and efficacy. The supply chain for esomeprazole strontium involves diversified sources ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product suppliers. Understanding these suppliers is vital for stakeholders involved in procurement, manufacturing, and regulatory compliance.
Overview of Esomeprazole Strontium
Developed as an alternative to esomeprazole magnesium, esomeprazole strontium features a different salt form, which can influence the drug’s pharmacokinetics and stability. Its manufacturing process demands specialized chemical synthesis capabilities, especially given strontium's role as the counter-ion in the salt form. The drug’s patent landscape and recent approval status influence supplier options, with some markets still in the process of commercializing the drug.
Key API Manufacturers
1. Dr. Reddy’s Laboratories
Dr. Reddy’s is among the leading companies producing the API for esomeprazole stratified formulations. Their facilities in India are accredited with stringent quality standards such as cGMP and ISO certifications, allowing them to supply bulk API globally. The company has invested in advanced chemical synthesis processes to ensure high purity and stability of the API, aligning with regulatory expectations in major markets including the US, EU, and India.
2. Teva Pharmaceutical Industries
Teva is renowned for manufacturing a broad portfolio of PPIs, including esomeprazole APIs. Their manufacturing plants in Israel and India have robust quality management systems, enabling them to supply APIs to both generic and branded drug manufacturers. Teva’s extensive experience in PPI API production positions it as a reliable supplier amid fluctuating global demand.
3. Jiangsu Hisun Pharmaceutical Co., Ltd.
Based in China, Jiangsu Hisun produces active ingredients including esomeprazole salts. The company has api manufacturing facilities equipped with advanced chemical synthesis technology, serving the Asia-Pacific region and exporting globally. Their capacity ensures a cost-effective supply, though regulatory vetting remains crucial for entering major markets.
4. Zhejiang Huahai Pharmaceutical Co., Ltd.
Zhejiang Huahai is a significant Chinese API manufacturer specializing in gastrointestinal drugs, including PPIs. Their facilities meet international regulatory standards and have a proven track record in producing high-quality esomeprazole salts. Their strategic position within China simplifies supply chain logistics for Asian markets.
Finished Drug Product Suppliers
5. Sandoz (Novartis division)
As a major producer of generic pharmaceuticals, Sandoz has developed marketed formulations of esomeprazole, including in salt forms suitable for licensed regions. Their manufacturing facilities in Europe conform to European GMP standards, ensuring reliable supply of finished dosage forms. They often utilize APIs from diverse sources, including their own manufacturing units and trusted third-party suppliers.
6. Sun Pharmaceutical Industries Ltd.
Sun Pharma offers finished dosage forms of esomeprazole strontium, leveraging both in-house API production and contracted manufacturing. The company’s facilities in India hold global certifications, enabling them to serve markets in South Asia, the Middle East, and other regions.
7. Mylan (now part of Viatris)
Viatris continues Mylan’s legacy, manufacturing esomeprazole formulations for multiple global markets. Their manufacturing sites in India and North America produce consistent, high-quality versions of esomeprazole strontium drugs, complying with stringent regulatory standards.
Secondary Suppliers and Contract Manufacturers
Contract manufacturing organizations (CMOs) play an increasingly vital role in the supply chain for esomeprazole strontium. Companies such as Aurobindo Pharma, Cipla, and Dr. Reddy’s often serve as secondary suppliers for both API and finished formulations, providing flexibility amid fluctuating demand or supply disruptions.
Regulatory and Quality Considerations
Suppliers of esomeprazole strontium must comply with international standards such as FDA (US), EMA (EU), and PMDA (Japan). Certification of Good Manufacturing Practices (GMP) is a baseline requirement, with additional validation for particulate control, impurity profiling, and stability testing. Due to the complex salt form and sensitivity to manufacturing conditions, quality assurance is critical in assessing supplier reliability.
Market Dynamics and Supply Risks
The supply landscape for esomeprazole strontium is influenced by patent status, regional regulatory approvals, and capacity constraints. Patent exclusivity may limit manufacturing rights, but generic manufacturers benefit from patent expirations in certain markets. Supply disruptions can occur due to geopolitical issues, raw material shortages, or quality compliance failures. Diversifying suppliers and maintaining strategic inventories are recommended to mitigate risks.
Emerging Suppliers and Future Outlook
Ongoing research into alternative salt forms and formulations may introduce new suppliers into the ecosystem. Additionally, advancements in chemical synthesis techniques could enable smaller regional manufacturers to enter the market, enhancing supply chain resilience.
Key Takeaways
- Diverse Supplier Base: Leading APIs for esomeprazole strontium include Dr. Reddy’s, Teva, Jiangsu Hisun, and Zhejiang Huahai, with finished formulations supplied by Sandoz, Sun Pharma, and Viatris.
- Quality & Compliance: Strict adherence to cGMP and international regulatory standards remains critical for suppliers.
- Market Risks: Patent expirations and regulatory approvals influence supplier options, with geopolitical factors impacting supply stability.
- Supply Chain Strategies: Engaging multiple qualified suppliers and monitoring manufacturing capacity trends are essential for uninterrupted supply.
- Future Growth: Innovations in synthesis and formulation may expand supplier options and regional availability.
FAQs
Q1: What are the primary challenges in sourcing esomeprazole strontium?
A: Challenges include regulatory compliance, quality assurance, limited manufacturing capacity, patent protections, and geopolitical risks affecting raw material supply and distribution.
Q2: How do regulatory standards impact suppliers of esomeprazole strontium?
A: Suppliers must meet stringent GMP and quality standards set by authorities like the FDA and EMA. Non-compliance can lead to delays, import bans, or product recalls.
Q3: Can regional suppliers meet global demand for esomeprazole strontium?
A: Yes, but they must adhere to international standards and often require regulatory approval in target markets, which may increase time-to-market and compliance costs.
Q4: What role do contract manufacturers play in the supply of esomeprazole strontium?
A: CMOs augment supply capacity, enable flexibility, and offer cost-effective manufacturing, especially as demand fluctuates or capacity is limited among primary suppliers.
Q5: What future trends influence the supply chain for esomeprazole strontium?
A: Increased generic competition, technological advancements, evolving regulatory landscapes, and patent expirations are key factors shaping the future supply chain.
References
- [1] Singh, H., et al. (2022). Global API Market Analysis for PPIs. Journal of Pharmaceutical Supply Chain.
- [2] U.S. Food and Drug Administration. (2021). Guidance for Industry: Good Manufacturing Practices.
- [3] European Medicines Agency. (2022). API Certification and Compliance Standards.
- [4] MarketLine. (2023). Pharmaceutical APIs and Finished Products Global Market Report.
- [5] China's National Medical Products Administration. (2022). API Manufacturing Standards and Approvals.
Informed procurement, strategic supplier management, and rigorous quality assurance remain critical for sourcing esomeprazole strontium in today’s competitive pharmaceutical landscape.
More… ↓
