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Suppliers and packagers for steglatro
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steglatro
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363-03 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03) | 2017-12-19 |
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363-06 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06) | 2017-12-19 |
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803 | NDA | Merck Sharp & Dohme LLC | 0006-5363-07 | 500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07) | 2017-12-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: STEGLATRO (Ertugliflozin)
Introduction
STEGLATRO (ertugliflozin) is an oral antidiabetic medication developed by Pfizer, approved for managing type 2 diabetes mellitus (T2DM). As a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors class, STEGLATRO enhances urinary glucose excretion, thereby reducing blood glucose levels. Given its significance in the diabetes treatment landscape, understanding its supply chain and key suppliers is vital for stakeholders across the pharmaceutical industry, including manufacturers, distributors, and healthcare providers. This analysis provides an in-depth overview of the suppliers involved in the manufacturing, API sourcing, and distribution of STEGLATRO.
Manufacturing and API Supply Chain Overview
The production of STEGLATRO involves several critical stages, primarily the sourcing of high-purity active pharmaceutical ingredients (APIs), formulation, packaging, and distribution. The API—ertugliflozin—is the cornerstone of the drug, and its availability hinges on robust supply chain management, quality standards, and regulatory compliance.
API Suppliers for Ertugliflozin
1. Contract Manufacturers and API Suppliers
Since the approval of STEGLATRO in 2017, Pfizer has predominantly relied on strategic partnerships with multiple suppliers to secure the API raw material. These suppliers are primarily based in Asia—especially China and India—owing to their capacity to produce API at scale under rigorous quality standards.
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China-based Suppliers: Companies such as Sino Biopharmaceutical Ltd. and Suzhou Tianlong Pharmaceutical Co., Ltd. have historically been involved in SGLT2 inhibitor API supply, leveraging China's robust active pharmaceutical ingredient (API) manufacturing infrastructure.
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India-based Suppliers: Firms like Hetero Labs Ltd., Sun Pharmaceutical Industries Ltd., and Aurobindo Pharma are notable players in the API market for antidiabetic agents, with their manufacturing facilities accredited by regulatory authorities such as the WHO, USFDA, and EMA.
2. Key Attributes of API Suppliers
- Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practice (GMP) standards, and many have received certifications from USFDA, EMA, and other regulatory bodies.
- Quality Assurance: High-purity API (>99%) is essential for drug safety and efficacy.
- Supply Reliability: Capacity to meet Pfizer's production schedule, especially amid global supply chain disruptions.
Formulation and Finished Product Manufacturers
While Pfizer maintains control over the final formulation and packaging of STEGLATRO, some contract manufacturing organizations (CMOs) are engaged for specific processes, including tablet compression and packaging. These CMOs are typically located in North America and Europe, ensuring compliance with regional quality standards.
Distribution and Supply Partners
Following manufacturing, distribution logistics are handled via Pfizer's global supply chain network. The company collaborates with major pharmaceutical distributors and specialty pharmacies to ensure the availability of STEGLATRO across markets. Key distribution partners include:
- McKesson Corporation
- AmerisourceBergen
- Cardinal Health
These distributors manage the downstream supply, ensuring the drug reaches healthcare providers, pharmacies, and hospitals worldwide.
Strategic Considerations in Supplier Selection
Pfizer's supplier strategy emphasizes securing reliable sources of high-quality API, minimizing supply chain risks, and maintaining regulatory compliance. In recent years, suppliers have faced challenges such as geopolitical uncertainties, trade tensions, and the COVID-19 pandemic, compelling Pfizer to diversify its sourcing footprint.
Supply Chain Challenges and Risks
- Global Supply Disruptions: The pandemic exposed vulnerabilities in API supply chains concentrated in Asia, prompting efforts to diversify suppliers.
- Regulatory Variability: Differing standards among suppliers necessitate rigorous auditing and validation processes.
- Pricing Pressures: Intense competition among API manufacturers influences supplier negotiations and costs.
Emerging Trends and Future Outlook
- Vertical Integration: Pfizer and other pharma companies might pursue vertical integration to oversee APIs production directly.
- Sustainable Sourcing: Growing emphasis on environmentally sustainable manufacturing practices.
- Supply Chain Digitization: Implementation of advanced analytics to monitor and predict supply chain risks.
Conclusion
The supply of STEGLATRO hinges on a complex network of API suppliers, predominantly based in China and India, backed by rigorous quality controls and regulatory adherence. Pfizer's strategic diversification and supply chain management aim to ensure steady availability amidst global disruptions. As the demand for innovative antidiabetic therapies rises, the stability and resilience of this supply network will be critical to market success.
Key Takeaways
- The API for STEGLATRO predominantly comes from China and India, with suppliers certified under international standards.
- Securing high-quality, compliant raw materials is vital to maintaining drug efficacy and safety.
- Diversification of suppliers mitigates risks associated with geopolitical and pandemic-related disruptions.
- Strategic partnerships with reliable CMOs support Pfizer’s manufacturing and distribution needs.
- Ongoing efforts focus on supply chain resilience, sustainability, and embracing digital tools for risk management.
FAQs
Q1: Who are the primary API manufacturers for STEGLATRO?
Most API production is sourced from Chinese and Indian GMP-certified suppliers, including companies like Suzhou Tianlong Pharmaceutical and Hetero Labs.
Q2: Does Pfizer manufacture the API in-house for STEGLATRO?
Pfizer primarily relies on contracted suppliers for the API; its core manufacturing facilities focus on formulation, packaging, and distribution.
Q3: What are the supply chain risks associated with STEGLATRO?
Key risks include geopolitical tensions, supply disruptions from Asia, regulatory compliance issues, and global events like pandemics.
Q4: How does Pfizer ensure API quality and regulatory compliance?
Through stringent qualification procedures, supplier audits, certification verification, and extensive quality control testing.
Q5: Are there plans to diversify API suppliers for STEGLATRO?
Yes, Pfizer is actively exploring new sourcing options to enhance supply chain resilience and reduce dependency on specific regions.
Sources:
[1] Pfizer. (2017). FDA Approval of STEGLATRO (ertugliflozin).
[2] US Food and Drug Administration. (2017). Official approval documentation.
[3] Industry Reports. (2022). Global API Market Trends.
[4] Pfizer Annual Report. (2022). Supply Chain and Manufacturing Strategies.
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