Suppliers and packagers for diovan

diovan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0358-34	90 TABLET in 1 BOTTLE (0078-0358-34)	2001-07-01
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0359-34	90 TABLET in 1 BOTTLE (0078-0359-34)	2001-07-01
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0360-34	90 TABLET in 1 BOTTLE (0078-0360-34)	2001-07-01
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283	NDA	Novartis Pharmaceuticals Corporation	0078-0423-15	30 TABLET in 1 BOTTLE (0078-0423-15)	2001-07-01

Suppliers for the Pharmaceutical Drug: DIOVAN

Last updated: July 27, 2025

Introduction

Diovan, the brand name for the generic pharmaceutical drug valsartan, is a widely prescribed angiotensin II receptor blocker (ARB) used primarily to treat hypertension and heart failure. As a cornerstone medication in cardiovascular therapy, Diovan's global demand intensifies competition among suppliers. Identifying leading suppliers, understanding their position in the supply chain, and analyzing the implications of their manufacturing capacities are critical for healthcare providers, pharmaceutical companies, and investors aiming to ensure drug availability, quality, and cost-effectiveness.

Overview of Diovan and its Market Dynamics

Launched by Novartis in 1996, Diovan became one of the top-selling antihypertensive medications worldwide. Its efficacy in reducing blood pressure and preventing cardiovascular events catapulted it into widespread clinical use (1). The drug's patent expiration in many regions prompted the emergence of multiple generic manufacturers, intensifying competitive pressures and diversifying the supplier landscape.

The global Diovan market is characterized by a mix of patented brand manufacturers and numerous generics producers. The key factors influencing supplier selection include regulatory compliance, manufacturing capacity, sourcing of active pharmaceutical ingredients (APIs), quality control standards, and distribution logistics.

Major Suppliers of Diovan

1. Novartis AG (Original Manufacturer)

Novartis holds the original patent rights for Diovan and remains a significant supplier, particularly during its patent-protected period. The company's expansive manufacturing network and quality assurance systems have positioned it as a reliable but higher-cost source of the drug globally. Post-patent expiry, Novartis transitioned toward strategic partnerships and licensing to sustain its market relevance and API supply chain control.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

A Chinese pharmaceutical powerhouse, Zhejiang Huahai has emerged as a leading supplier of generic valsartan, including versions of Diovan. The company gained prominence due to its extensive API manufacturing capabilities, competitive pricing, and compliance with international regulatory standards. However, it encountered regulatory challenges in 2019 following the discovery of a contaminated API batch, highlighting the importance of supply chain oversight.

3. Hetero Labs Limited

India-based Hetero is a prolific producer of generic valsartan APIs. Its manufacturing facilities are certified by global agencies such as USFDA and EMA, facilitating exports worldwide. Hetero supplies APIs to various generic drug manufacturers and has diversified its product portfolio to strengthen its position in the cardiovascular therapeutic area.

4. Zydus Cadila

Another Indian pharmaceutical entity, Zydus Cadila, produces high-quality APIs, including valsartan. The company emphasizes stringent quality protocols aligning with international standards, making it a trusted supplier for generic formulations globally.

5. Aurobindo Pharma Limited

Known for its robust API manufacturing infrastructure, Aurobindo supplies valsartan APIs to both the generic market and branded formulations. Its strategic investments in manufacturing capacity and quality systems have enabled it to meet increasing regulatory requirements.

6. Other Notable Suppliers

• Lupin Limited: An established Indian API producer with a significant share in the valsartan market.
• Shaanxi Jinhui Pharmaceutical Co., Ltd.: Chinese API manufacturer expanding operations in cardiovascular compounds.
• Teva Pharmaceutical Industries: Although primarily a drug formulary company, Teva sources APIs globally and could be involved indirectly in Diovan supply via partnerships.

Regulatory and Supply Chain Considerations

Regulatory agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and China Food and Drug Administration (CFDA) impose strict standards on manufacturing facilities. Suppliers with certified facilities provide assurance of consistent API quality, a vital consideration for pharmaceutical companies and healthcare providers.

Supply chain stability, especially in light of recent disruptions—such as the Active Pharmaceutical Ingredient shortages in 2019 and the COVID-19 pandemic—remains a core concern. Many governments have encouraged domestic API manufacturing to mitigate dependence on specific suppliers, notably those in China and India.

Emerging Trends and Future Outlook

The globalization of API manufacturing, combined with regulatory tightening and quality assurance demands, influences supplier dynamics. Companies investing in advanced manufacturing technologies, renewable energy use, and enhanced quality controls secure competitive advantages.

Furthermore, biosimilar and innovative ARB therapies may impact Diovan's market share, prompting existing suppliers to diversify or upgrade their product lines. The evolving landscape indicates an increasing prominence of suppliers with robust regulatory compliance, sustainable practices, and scalable manufacturing capacity.

Conclusion

Diving into the supplier landscape for Diovan reveals a complex ecosystem centered on global API producers, with Zhejiang Huahai, Hetero, Zydus, and Aurobindo playing prominent roles. The transfer from patent exclusivity to generic competition has democratized supply sources, reducing costs but accentuating the importance of quality and regulatory adherence. Long-term supply stability hinges on diversification, regulatory compliance, and strategic capacity investment.

Key Takeaways

• Multiple global suppliers, primarily from India and China, dominate the API manufacturing landscape for Diovan.
• Regulatory compliance and certifications are critical for supplier credibility and supply continuity.
• Quality control issues, such as the Zhejiang Huahai incident, underscore the importance of rigorous supplier oversight.
• Supply chain resilience can be enhanced through diversification of supplier base and local manufacturing initiatives.
• Emerging regulatory and market trends suggest an emphasis on sustainable production practices and capacity expansion.

FAQs

1. What are the primary countries producing APIs for Diovan?
   India and China lead API manufacturing for valsartan due to cost efficiencies and large-scale production capacities.

2. How does patent expiration affect Diovan suppliers?
   Patent expiry allows multiple generic manufacturers to produce and supply valsartan, increasing market competition and diversifying suppliers.

3. What regulatory standards govern API suppliers?
   Suppliers must comply with standards set by agencies such as FDA, EMA, and CFDA, which require facility certifications, consistent quality, and thorough documentation.

4. Are there risks associated with reliance on Chinese and Indian API producers?
   Yes, risks include regulatory non-compliance, quality lapses, geopolitical tensions, and supply chain disruptions, emphasizing the need for supply diversification.

5. What measures can pharmaceutical companies take to ensure supply chain security for Diovan?
   Strategies include qualifying multiple suppliers, maintaining safety stock, overseeing quality assurance processes, and investing in local manufacturing facilities.

References

1. Newman, C. (2018). "The Rise of Valsartan: Market Dynamics and Regulatory Challenges." Journal of Pharmaceutical Markets, 12(4), 45-52.