Suppliers and packagers for generic pharmaceutical drug: VALSARTAN

VALSARTAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novitium Pharma	VALSARTAN	valsartan	SOLUTION;ORAL	214102	ANDA	ANI Pharmaceuticals, Inc.	70954-310-10	120 mL in 1 BOTTLE, PLASTIC (70954-310-10)	2021-11-02
Novitium Pharma	VALSARTAN	valsartan	SOLUTION;ORAL	214102	ANDA	ANI Pharmaceuticals, Inc.	70954-310-20	473 mL in 1 BOTTLE, PLASTIC (70954-310-20)	2021-11-02
Novitium Pharma	VALSARTAN	valsartan	SOLUTION;ORAL	214102	ANDA	Lifsa Drugs LLC	72336-910-79	120 mL in 1 BOTTLE, PLASTIC (72336-910-79)	2022-04-04
Novitium Pharma	VALSARTAN	valsartan	SOLUTION;ORAL	214102	ANDA	Lifsa Drugs LLC	72336-910-89	473 mL in 1 BOTTLE, PLASTIC (72336-910-89)	2022-04-04
Rubicon	VALSARTAN	valsartan	SOLUTION;ORAL	216460	ANDA	Advagen Pharma Ltd	72888-184-13	473 mL in 1 BOTTLE (72888-184-13)	2025-06-05
Rubicon	VALSARTAN	valsartan	SOLUTION;ORAL	216460	ANDA	Advagen Pharma Ltd	72888-184-48	120 mL in 1 BOTTLE (72888-184-48)	2025-06-05

Suppliers for the Pharmaceutical Drug: Valsartan

Last updated: July 27, 2025

Introduction

Valsartan, an angiotensin II receptor blocker (ARB), is widely prescribed for managing hypertension, heart failure, and protecting the kidneys in diabetic patients. Since its market introduction, numerous suppliers globally have engaged in the manufacturing, distribution, and supply of valsartan. However, the drug's supply chain has experienced significant disruptions due to safety recalls, regulatory scrutiny, and supply chain complexities, especially following contamination issues in 2018. Understanding the key suppliers in the valsartan supply chain is vital for pharmaceutical companies, healthcare providers, and policymakers to ensure drug availability, regulatory compliance, and risk management.

Global Manufacturing Landscape of Valsartan

Major Pharmaceutical Companies and Contract Manufacturers

Global supply hinges on a mixture of branded drug manufacturers and generic producers. The original innovator company, Novartis, introduced valsartan in 1996, but its production gradually shifted as patent protections expired. Today, the landscape involves both originators and a wide network of contract manufacturing organizations (CMOs), especially in Asia.

1. Novartis

• Role: Original developer and proprietary supplier of valsartan in some markets before patent expiry.
• Supply: Continues to supply branded formulations and licenses manufacturing rights in different regions.

2. Teva Pharmaceutical Industries

• Role: One of the largest generic drug manufacturers globally, possessing substantial manufacturing capacity for valsartan (Sources: Teva Annual Reports).
• Manufacturing: Operates multiple facilities in Israel and India, producing large volumes for global distribution.

3. Mylan (now part of Viatris)

• Role: Major supplier of generic valsartan, with extensive manufacturing facilities across India and Europe.
• Significance: One of the earliest firms to resume supply after the 2018 recall, contributing significantly to global availability.

4. Zhejiang Huahai Pharmaceutical

• Role: Chinese manufacturer pivotal in the valsartan supply chain before the 2018 contamination scandal.
• Contamination and Recall: Identified as the source of nitrosamine impurity (N-Nitrosodimethylamine, NDMA) contamination, leading to global recalls (Sources: FDA, EMA).

5. Zhejiang Tianyu Pharmaceutical Co. and Other Chinese Manufacturers

• Role: Several Chinese firms produce valsartan or intermediates. Some emerged as backup suppliers or increased capacity post-recall.

6. Zydus Cadila, Advanz Pharma, and Other Indian Generics Firms

• Role: These companies increased production capacities to fill gaps left by halted Chinese suppliers, contributing significantly to global supply.

Contract Manufacturing Organizations (CMOs) and API Suppliers

The supply of valsartan relies heavily on Active Pharmaceutical Ingredient (API) manufacturers. Many operate behind the scenes, manufacturing for multiple branded and generic firms.

• Huahai Pharmaceutical (China): PCA supplier whose contamination issues underscored the importance of supply chain oversight.
• Hetero Drugs (India): Major API producer for valsartan, with high-volume manufacturing capacities.
• Aarti Industries (India), Sinopharm Chemical Reagent Co. Ltd., and Zhejiang East Asia Pharmaceutical Co. Ltd.: Additional key API suppliers distributed across China and India.

Supply Chain Challenges and Recent Developments

The 2018 contamination incident profoundly impacted the supply chain, prompting increased scrutiny, diversification, and regulatory actions. Key steps include:

• Recalls and Market Withdrawals: Multiple regulatory bodies, including the FDA and EMA, ordered recalls due to NDMA contamination originating from Chinese suppliers.
• Diversification of Suppliers: Many pharmaceutical firms sought alternative vendors, including Indian manufacturers and new Chinese producers, to mitigate dependency risks.
• Enhanced Oversight: Regulatory agencies implemented stricter GMP standards, requiring detailed supplier audits, quality verification, and impurity testing.

Regional Dynamics and Market Share

United States

The FDA identified Zhejiang Huahai as a primary source of contaminated valsartan in 2018, leading to a nationwide recall. Post-recall, Indian manufacturers like Mylan and Zydus Cadila increased market share due to their cleaner supply chains. The U.S. market now features a diverse array of suppliers, with some companies establishing local API manufacturing capabilities.

European Union

The EMA coordinated cross-border recalls and implemented rigorous API sourcing standards. European manufacturers such as Novartis and their licensed suppliers maintained supply, while intensified audits of Chinese and Indian API suppliers became routine.

Asia-Pacific

China remains the dominant API producer, with Zhejiang Huahai, Zhejiang Tianyu, and others holding significant market positions. Indian firms like Hetero, Aurobindo, and Cadila Pharmaceuticals expanded their capacities to meet global demand, reducing dependency on Chinese sources.

Regulatory Impact and Supply Chain Resilience

The 2018 NDMA incident prompted policymakers to overhaul drug supply chain frameworks. The US FDA introduced the Drug Supply Chain Security Act (DSCSA), emphasizing transparency and traceability. European regulators adopted new GMP guidelines and increased supplier assessments. These shifts aim to foster resilient supply chains, diversify sourcing, and minimize contamination risks.

Consolidation and Future Outlook

The industry reflects a trend toward consolidation among API manufacturers, with mergers and collaborations enhancing capacity. Notable developments include:

• Vertical Integration: Some pharmaceutical firms are investing directly in API manufacturing plants to gain better control over quality and supply.
• Global Diversification: Companies are establishing or expanding facilities in Southeast Asia, Africa, and Latin America to mitigate geopolitical and supply risks.

Conclusion

The supply of valsartan is characterized by a multi-layered ecosystem involving patent holders, global API producers, contract manufacturers, and regulators. The industry continues to evolve post-2018, emphasizing supply chain robustness, impurity control, and diversification. Stakeholders should monitor developments in API sourcing, regulatory requirements, and technological advancements to navigate potential risks and ensure continuous drug availability.

Key Takeaways

• Diverse Supplier Base: The valsartan supply chain includes leading Chinese API manufacturers like Zhejiang Huahai and Indian firms such as Hetero and Zydus Cadila.
• Regulatory Scrutiny: Major incidents, notably the NDMA contamination in 2018, led to increased oversight and a push for supply chain diversification.
• Market Dynamics: The U.S. and European markets are now served by a broader set of suppliers, reducing dependency on a single source and mitigating contamination risks.
• Supply Chain Resilience: Future strategies involve expanding API capacity, enhancing quality controls, and establishing local manufacturing hubs.
• Industry Trends: Mergers, investments in vertical integration, and diversification into Southeast Asia and Latin America will shape the future landscape.

FAQs

1. Who are the leading suppliers of valsartan globally?
Key suppliers include Chinese companies Zhejiang Huahai and Zhejiang Tianyu, Indian firms like Hetero Drugs and Zydus Cadila, and multinational companies such as Teva and Mylan. The landscape continues to diversify post-recall.

2. What caused the 2018 recall of valsartan products?
The recall was triggered by the detection of nitrosamine impurities (NDMA and N-Nitrosodimethylamine) originating primarily from Chinese API manufacturers, especially Zhejiang Huahai, raising safety concerns about contaminated composites in the drug products.

3. How has the supply chain for valsartan changed after the 2018 incident?
Manufacturers diversified sources, increased oversight of Chinese API producers, and expanded partnerships with Indian manufacturers. Regulatory agencies mandated stricter testing, traceability, and GMP standards.

4. Are there regional differences in valsartan suppliers?
Yes. The U.S. relies on suppliers from India and China, with increased domestic API manufacturing. Europe enforces stringent supplier assessments, primarily sourcing from compliant Chinese and Indian producers. Asia continues to be dominant, but diversification efforts are ongoing worldwide.

5. What is the future outlook for valsartan suppliers?
The future involves increased industry consolidation, vertical integration, and expanded capacity in Asia, Latin America, and possibly North America. Emphasis on impurity control, regulatory compliance, and sustainable sourcing will define the evolving landscape.

References

[1] U.S. Food and Drug Administration (FDA). "Valsartan recalls and safety alerts." 2018.

[2] European Medicines Agency (EMA). "Valsartan EAIMS updates." 2018.

[3] Teva Annual Report 2022. "Global manufacturing and supply."

[4] Zhejiang Huahai Pharmaceutical. "Quality and regulatory compliance report," 2018.

[5] Hetero Drugs. "API manufacturing capacity expansion," 2021.