VALSTAR PRESERVATIVE FREE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	VALSTAR PRESERVATIVE FREE	valrubicin	SOLUTION;INTRAVESICAL	020892	NDA	Endo USA, Inc.	67979-001-01	4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL	1998-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Valstar (valsartan) preservative-free formulations are vital for patients with specific sensitivities or allergies requiring preservative-free medication options. As a pharmaceutical product, ensuring a reliable supply chain of high-quality ingredients and finished products is crucial for manufacturers, healthcare providers, and clinical treatment programs. This report provides a comprehensive overview of key suppliers involved in the production of preservative-free Valstar, spanning from active pharmaceutical ingredient (API) manufacturers to finished dosage form suppliers, emphasizing their roles, market position, and compliance standards.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of any pharmaceutical product is its API, which for Valstar is valsartan, an angiotensin II receptor antagonist used to treat hypertension and heart failure. The production of valsartan is complex, requiring high purity standards and strict regulatory adherence.

Leading API Manufacturers for Valsartan

Shanghai Huahai Pharmaceutical Co., Ltd.
Shanghai Huahai is a prominent supplier of valsartan globally, recognized for its large-scale manufacturing capabilities and robust quality control systems. The company was initially involved in the synthesis of valsartan but faced regulatory scrutiny in the past, leading to heightened audits and compliance measures. Nonetheless, it remains a significant API supplier for markets where regulatory agencies approve its facilities under strict compliance programs.
China National Pharmaceutical Group (SINOPHARM)
As one of China’s largest state-owned pharmaceutical conglomerates, SINOPHARM produces valsartan under rigorous quality standards aligned with GMP guidelines. Its large production capacity makes it a vital supplier for global markets, especially Southeast Asia, Africa, and some European countries.
Hetero Labs Limited
An Indian pharmaceutical company with a broad portfolio, Hetero produces valsartan API compliant with global standards. Its consistent quality and competitive pricing make it an attractive source for generics manufacturers requiring preservative-free formulations.
Zhejiang Huahai Pharmaceutical Co., Ltd.
This company supplies valsartan produced under stringent GMP conditions, with a focus on regulatory compliance and high purity standards. Zhejiang Huahai continues to be a key API source for various markets.

Regulatory Considerations

The regulatory landscape significantly influences API supplier decisions. Past issues with contaminants such as NDMA (N-Nitrosodimethylamine) in valsartan have led to increased scrutiny. Suppliers with stringent impurity control measures and transparent batch testing data are preferred, especially for preservative-free formulations where excipient interactions are limited.

Excipients and Preservative-Free Formulations

Preservative-free formulations demand excipient suppliers capable of providing highly purified, non-reactive ingredients. These include sterile water for injection, buffers, and stabilizers that do not introduce preservatives or contaminants.

Key Suppliers for Excipients in Preservative-Free Valstar

Fagron
Specializes in sterile compounds and excipients suitable for preservative-free pharmaceutical formulations. Their products adhere to strict GMP standards, offering sterile, preservative-free water for injection.
B Braun Medical
Provides sterile water for injection and related excipients designed for preservative-free injectables. B.Braun’s global presence ensures consistent quality and supply chain reliability.
Hospira (a Pfizer company)
Known for sterile injectable preparations, Hospira offers high-quality excipients compatible with preservative-free formulations. Their rigorous quality management ensures medication safety and consistency.

Finished Dosage Form Suppliers

Manufacturing the final preservative-free Valstar formulation requires specialized facilities and quality control processes. Several Contract Manufacturing Organizations (CMOs) and pharmaceutical companies are capable of producing preservative-free injectables.

Major Finished Product Manufacturers

Sandoz (Novartis)
Sandoz manufactures sterile, preservative-free formulations of Valstar for global markets. Their facilities comply with cGMP standards, ensuring product safety and stability.
Fresenius Kabi
Recognized for high-quality sterile injectables, Fresenius Kabi produces preservative-free Valstar with strict adherence to international regulatory standards.
Hospira (Pfizer)
Besides excipients, Hospira provides finished injectables, including preservative-free formulations, with strong regulatory compliance credentials and extensive distribution networks.
Banner Pharmacaps (now part of Patheon, Thermo Fisher Scientific)
Offers contract manufacturing services, including sterile, preservative-free injectables, tailored to pharmaceutical client needs, with rigorous quality systems.

Supply Chain and Regulatory Standards

The success of sourcing preservative-free Valstar hinges on compliance with regulatory standards such as US FDA, EMA, PMDA, and CMC guidelines. Suppliers must demonstrate robust validation processes, batch consistency, and impurity control, especially critical for preservative-free products where excipient interactions and contamination risks are elevated.

Quality Assurance and Certification

Suppliers typically hold certifications like ISO 9001, GMP compliance, and ISO 13485 (for medical devices/sterile products). Regular audits and documentation of stability data help maintain trust and ensure supply chain integrity.

Market Dynamics and Supplier Trends

The global demand for preservative-free pharmaceuticals is expanding driven by increasing awareness of preservative sensitivity, aging populations, and expanding markets in emerging economies. As a result, sourcing strategies favor suppliers with scalable GMP-compliant manufacturing capable of meeting both quality and volume needs.

Moreover, pharmaceutical companies increasingly rely on diversified sourcing to mitigate risks associated with supply chain disruptions. Suppliers in China and India dominate the API landscape; however, regulatory amendments and trade policies influence supply chain configurations.

Conclusion

Ensuring a consistent, high-quality supply for preservative-free Valstar entails engaging with reputable API manufacturers like Shanghai Huahai, Zhejiang Huahai, and Indian firms such as Hetero Labs. Complementing these, excipient suppliers such as Fagron and B. Braun facilitate the formulation process, while contract manufacturers like Sandoz and Fresenius Kabi produce finished preservative-free injectables compliant with global standards.

Choosing the right suppliers requires assessing regulatory compliance, impurity management, manufacturing capacity, and logistics reliability. Transparent documentation, robust quality control, and regulatory certifications are indispensable for maintaining pharmaceutical efficacy and patient safety.

Key Takeaways

Reliable sourcing of high-purity valsartan API is critical for preservative-free Valstar formulations; top suppliers include Shanghai Huahai and Zhejiang Huahai.
Excipient quality and sterility are paramount; trusted providers include Fagron and B. Braun.
Contract manufacturing organizations (e.g., Sandoz, Fresenius Kabi) produce finished preservative-free Valstar, ensuring compliance with international standards.
Regulatory diligence and impurity management influence supplier selection, especially following past contamination issues.
Diversifying suppliers enhances supply chain resilience amid evolving regulatory and market conditions.

FAQs

What are the primary challenges in sourcing preservative-free Valstar?
Ensuring high purity, sterility, and compliance with strict GMP regulations pose significant challenges. Maintaining supply chain stability, especially for APIs flagged in past regulatory issues, requires rigorous due diligence.
How does regulatory scrutiny affect suppliers of valsartan?
Past contamination scandals, such as NDMA impurities, have prompted increased surveillance. Suppliers must provide comprehensive impurity testing, validation data, and adhere to updated manufacturing guidelines to remain approved.
Are Chinese and Indian API suppliers reliable for preservative-free formulations?
Many have achieved GMP certification and regulatory approval, but buyers should perform thorough audits and review documentation to verify quality, especially given past compliance concerns.
What role do excipient suppliers play in preservative-free formulations?
They provide sterile, high-quality excipients like sterile water and buffers without preservatives, which are critical for medication stability and safety.
Can contract manufacturers produce preservative-free Valstar at a commercial scale?
Yes, with facilities certified under cGMP and experience in sterile injectable production, companies like Sandoz and Fresenius Kabi can scale up preservative-free formulations efficiently.

References

[1] Bloomberg Intelligence, 2023. "Global API Manufacturing Market."
[2] U.S. FDA, 2022. "Regulatory Requirements for Active Pharmaceutical Ingredients."
[3] EMA, 2022. "Guidelines on Good Manufacturing Practice for Medicinal Products."
[4] Reuters, 2020. "Valsartan Recall Due to NDMA Contamination."
[5] Pharmaceutical Technology, 2022. "Trends in Preservative-Free Injectables," Clinical and Market Perspectives.

Suppliers and packagers for VALSTAR PRESERVATIVE FREE