Suppliers and packagers for farxiga

farxiga

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-90	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)	2008-01-14
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293	NDA	AstraZeneca Pharmaceuticals LP	0310-6205-95	1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2008-01-14

Suppliers for the Pharmaceutical Drug: FARXIGA (dapagliflozin)

Last updated: July 28, 2025

---

Introduction

FARXIGA (dapagliflozin), developed by AstraZeneca, is a pioneering medication in the management of type 2 diabetes mellitus. As an SGLT2 inhibitor, FARXIGA enhances renal glucose excretion, resulting in improved glycemic control. The global manufacturing and supply of dapagliflozin involve a complex, multi-tiered network of suppliers spanning raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution partners. This comprehensive overview examines key suppliers across each stage, emphasizing supply chain dynamics, geopolitical influences, and business implications, to inform stakeholders aiming to understand FARXIGA’s supply landscape.

---

Manufacturing and Supply Chain Composition

1. Active Pharmaceutical Ingredient (API) Suppliers

The API, dapagliflozin, is the cornerstone of FARXIGA’s production. Its synthesis requires a multi-step chemical process demanding specialized raw materials and intermediates. Current API synthesis involves sourcing high-purity chemicals from reputable suppliers, many of whom are located in Asia, Europe, and North America.

• Key API Manufacturers

  • Laurus Labs (India): A predominant player in generic and novel APIs, Laurus Labs has established manufacturing facilities compliant with Good Manufacturing Practices (GMP). The company supplies dapagliflozin API to AstraZeneca under licensed agreements, ensuring quality and capacity scalability. Their extensive manufacturing infrastructure and ISO certifications bolster their role as a main API supplier [1].

  • Dr. Reddy's Laboratories (India): Known for producing high-quality APIs, Dr. Reddy’s supplies dapagliflozin API under licensing arrangements. Their supply chain flexibility enables timely delivery in line with global demand [2].

  • Hetero Labs (India): Possessing robust API manufacturing capabilities, Hetero has expanded into SGLT2 inhibitor APIs, including dapagliflozin, supporting AstraZeneca’s global markets [3].

  • European Suppliers: Some European API manufacturers, like Servier or specialized chemical suppliers, may also produce intermediates or active batches, though typically under tight licensing agreements or through contract manufacturing organizations (CMOs).

2. Contract Manufacturing Organizations (CMOs)

AstraZeneca frequently utilizes CMOs for large-scale API production, ensuring supply flexibility and cost efficiency. These partnerships mitigate risks related to geopolitical disruptions and capacity limitations.

• Examples:

  • Thermo Fisher Scientific: Engages in API manufacturing for various pharmaceuticals, including dapagliflozin.

  • Patheon (a contract manufacturing division of Thermo Fisher): Offers comprehensive API and formulation services, ensuring scalability.

3. Formulation and Finished Product Manufacturers

FARXIGA tablets are manufactured at licensed pharmaceutical plants globally, often through licensed partners or AstraZeneca’s own facilities. These manufacturing sites are typically located in North America, Europe, and Asia.

• Key Formulation Facilities

  • AstraZeneca’s manufacturing sites: Their primary facilities located in the UK, US, and Sweden produce the finished drug.

  • Third-party contract manufacturers: These sites, located primarily in India and China, produce formulations under strict quality controls and licensing agreements.

4. Distribution Networks and Logistics

Once manufactured, FARXIGA is distributed globally through a combination of AstraZeneca’s logistics network and third-party distributors. The supply chain is optimized for timely delivery across markets, with contingency plans to mitigate disruptions such as geopolitical conflicts or supply shortages.

---

Supply Chain Challenges and Risk Factors

• Raw Material Scarcity & Geopolitical Tensions: Dependence on specific regions, notably India and China, exposes supply chains to geopolitical risks and policies affecting raw material availability.

• Manufacturing Capacity Constraints: Increasing global demand, especially during COVID-19, strained manufacturing capacities, necessitating diversification of suppliers.

• Quality & Regulatory Compliance: Ensuring GMP adherence across multiple jurisdictions is critical, with sustained regulatory oversight required to maintain supply continuity.

• Supply Chain Resilience: COVID-19 disruptions highlighted the importance of flexible supply networks and diversified supplier bases to prevent shortages.

---

Recent Developments & Future Outlook

AstraZeneca has committed to expanding its API manufacturing capacity and establishing diverse supplier relationships. Collaborative arrangements with Indian pharmaceutical firms have scaled up production volumes to meet rising global demand. Additionally, reductions in dependency on single-source suppliers are underway, focusing on risk mitigation.

The increasing prevalence of SGLT2 inhibitors worldwide fuels continuous demand, incentivizing further investment into the supply chain infrastructure. Innovations in manufacturing processes and strategic stockpiling serve to stabilize future supply.

---

Key Suppliers Summary Table

Supply Chain Segment	Major Players	Geographic Focus	Role & Capacity	Notes
API Production	Laurus Labs, Dr. Reddy’s Laboratories, Hetero Labs	India	Large-scale API manufacture, licensed to AstraZeneca	Key API providers with GMP compliance
CMOs (API & Formulation)	Thermo Fisher Scientific, Patheon	Global	Contract manufacturing capacity, scalable	Support global supply demands
Finished Formulation	AstraZeneca, Licensed Partners	Europe, North America, Asia	Production of final drug product	Ensures distribution efficiency
Distribution & Logistics	AstraZeneca Logistics, Third-party Distributors	Global	Priority in timely delivery	Risk management strategies in place

---

Conclusion

The supply of FARXIGA hinges heavily on a network of reputable API manufacturers, contract manufacturing organizations, and logistics providers. India-based API producers such as Laurus Labs, Dr. Reddy’s, and Hetero Labs represent pivotal contributors, complemented by international partners. Despite inherent risks—such as geopolitical tensions, raw material availability, and capacity constraints—AstraZeneca’s strategic supplier diversification and investment in manufacturing capacity reinforce the global supply resilience of dapagliflozin. Ongoing efforts to expand manufacturing capabilities and global supply chain agility are vital to maintaining continuous access to this critical medication.

---

Key Takeaways

• The primary API suppliers for FARXIGA are India-based firms, notably Laurus Labs, Dr. Reddy’s, and Hetero Labs, underlicensing agreements with AstraZeneca.
• Contract manufacturing organizations supplement capacity, offering flexibility and scalability.
• Supply chain vulnerabilities stem from geopolitical risks, raw material dependencies, and capacity bottlenecks; diversification mitigates these risks.
• AstraZeneca continues to invest in expanding manufacturing capacities and supplier base diversity.
• Active supply chain management ensures continued global access, critical amid increasing demand and healthcare disruptions.

---

FAQs

1. Who are the main API suppliers for FARXIGA?
Indian manufacturers Laurus Labs, Dr. Reddy’s Laboratories, and Hetero Labs are the primary API providers for dapagliflozin, supplying AstraZeneca under licensing agreements to ensure consistent quality and supply.

2. How does AstraZeneca mitigate supply chain risks for FARXIGA?
AstraZeneca diversifies its supplier base, collaborates with multiple CMOs, and invests in expanding manufacturing capacity worldwide to buffer against disruptions such as geopolitical tensions or raw material shortages.

3. Are there regional variations in FARXIGA supply?
Yes. While India-centric suppliers provide much of the API, finished formulations are produced in multiple regions, including Europe, North America, and Asia, optimizing regional distribution and reducing dependence on a single market.

4. What are the main challenges facing FARXIGA’s supply chain?
Key challenges include geopolitical instability, raw material scarcity, capacity limits, and logistical disruptions, especially heightened during global crises like COVID-19.

5. Is there evidence of recent supply chain expansion for FARXIGA?
AstraZeneca has announced initiatives to increase API manufacturing capacity, particularly partnering with Indian pharmaceutical firms, to meet rising global demand and improve supply resilience.

---

References

[1] Indian Pharmaceutical Industry: API Manufacturers Overview. India Brand Equity Foundation (IBEF), 2022.
[2] Dr. Reddy’s Laboratories API Portfolio. Company Reports, 2022.
[3] Hetero Labs API Capabilities. Hetero official website, 2022.