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Last Updated: December 18, 2025

ZINC CHLORIDE - Generic Drug Details


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What are the generic sources for zinc chloride and what is the scope of freedom to operate?

Zinc chloride is the generic ingredient in two branded drugs marketed by Exela Pharma, Rk Pharma, Somerset, and Hospira, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for zinc chloride. Three suppliers are listed for this compound.

Summary for ZINC CHLORIDE
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 137
Clinical Trials: 891
Patent Applications: 5,133
What excipients (inactive ingredients) are in ZINC CHLORIDE?ZINC CHLORIDE excipients list
DailyMed Link:ZINC CHLORIDE at DailyMed
Recent Clinical Trials for ZINC CHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nextrast, Inc.PHASE1
University Medical Center GroningenPHASE3
European Group for Research In SchizophreniaPHASE3

See all ZINC CHLORIDE clinical trials

Pharmacology for ZINC CHLORIDE

US Patents and Regulatory Information for ZINC CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Somerset ZINC CHLORIDE zinc chloride INJECTABLE;INJECTION 216152-001 Oct 16, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira ZINC CHLORIDE IN PLASTIC CONTAINER zinc chloride INJECTABLE;INJECTION 018959-001 Jun 26, 1986 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rk Pharma ZINC CHLORIDE zinc chloride INJECTABLE;INJECTION 217625-001 Apr 14, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Exela Pharma ZINC CHLORIDE zinc chloride INJECTABLE;INJECTION 212007-001 May 21, 2021 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Zinc Chloride in the Pharmaceutical Sector

Last updated: July 29, 2025

Introduction

Zinc chloride (ZnCl₂) is a versatile inorganic compound with a broad spectrum of applications across various industries, including pharmaceuticals, cosmetics, and industrial manufacturing. In the pharmaceutical domain, zinc chloride's roles primarily revolve around its antiseptic, astringent, and catalytic properties. Although not a blockbuster drug, zinc chloride's activity as an active ingredient in topical formulations and as a reagent in drug synthesis influences its market trajectory. Understanding the evolving market dynamics, demand drivers, competitive landscape, and future financial trajectory is essential for industry stakeholders.

Market Overview and Key Applications

Zinc chloride’s pharmaceutical utilization predominantly arises from its antiseptic and wound-healing properties. It facilitates topical antifungal formulations, skin antiseptics, and astringents used in oral and dermatological preparations. Additionally, zinc chloride acts as a catalyst or reagent in drug synthesis, influencing pharmaceutical manufacturing processes.

Beyond pharmaceuticals, zinc chloride's applications in cosmetics (e.g., anti-acne preparations), dentistry (as a component in root canal treatments), and industrial applications like textile processing and water treatment underpin its diversified demand profile.

Market Drivers

1. Increasing Demand for Zinc-Related Therapeutics

The rising prevalence of skin infections, dermatological conditions, and oral health issues globally augments demand for antiseptic formulations containing zinc chloride. As a component of mouthwashes and topical treatments, zinc chloride remains pivotal in managing conditions like stomatitis and gingivitis, bolstering its pharmaceutical demand.

2. Growth in Pharmaceutical Manufacturing and API Synthesis

Zinc chloride’s role as a reagent in chemical synthesis is critical in manufacturing active pharmaceutical ingredients (APIs). The expanding pipeline of novel drugs and generic formulations sustains demand for high-quality zinc salts as catalysts and intermediates.

3. Rising Healthcare Spending and Market Access

Developing regions, notably Asia-Pacific, are experiencing increased healthcare expenditure. Enhanced access to healthcare services, coupled with a rise in dermatological and oral health products, drives zinc chloride consumption.

4. Advancements in Wound Care and Antiseptics

Innovations in topical formulations integrating zinc compounds result in improved efficacy, stability, and consumer acceptance. The global shift towards non-invasive and skin-friendly treatments contributes positively to zinc chloride's market outlook.

5. Stringent Regulatory Frameworks and Safety Profile

Zinc compounds possess a well-established safety profile, facilitating regulatory approvals and encouraging market penetration in medical and cosmetic products.

Market Restraints and Challenges

1. Limited Market Penetration of Zinc Chloride as an Active Pharmaceutical Ingredient

Compared to other zinc salts like zinc sulfate and zinc oxide, zinc chloride’s limited direct drug applications constrain its growth. Its primary use remains as an excipient or reagent rather than an active therapeutic agent.

2. Competition from Alternative Zinc Compounds

The availability of other zinc salts with similar or superior efficacy in particular applications creates competitive limitations. Zinc sulfate, for example, enjoys broader utilization in dietary supplements and oral health, overshadowing zinc chloride.

3. Regulatory Hurdles and Quality Standards

Ensuring consistent quality, purity, and regulatory compliance for pharmaceutical-grade zinc chloride poses challenges, especially in emerging markets with less stringent standards.

4. Market Volatility in Raw Material Prices

Fluctuations in the prices of raw materials, primarily zinc metal, directly impact the manufacturing costs of zinc chloride.

Competitive Landscape

Major players operating in the zinc chloride market include:

  • Uday Chemical Industries
  • Tianjin Zhongxin Chemical Industrial Co., Ltd.
  • Hefei ChemBless Chemical Co., Ltd.
  • Scharlau Microelements
  • American Elements

These companies focus on manufacturing pharmaceutical-grade zinc chloride, emphasizing purity, stability, and environmental compliance. Strategic initiatives involve capacity expansion, product diversification, and strengthening regional distribution networks.

Financial Trajectory and Market Forecast

Current Market Size

The global zinc chloride market was valued at approximately USD 200 million in 2022 (estimated), with pharmaceutical applications comprising a modest but steady share. The pharmaceutical segment is projected to grow at a Compound Annual Growth Rate (CAGR) of 4-6% through 2030, driven by increased demand for antiseptic and topical formulations [1].

Future Growth Drivers

  • Asia-Pacific dominance: Countries like India and China will remain primary consumption hubs due to expanding healthcare infrastructure and manufacturing capacities.
  • Innovation in formulations: Development of more effective and skin-friendly topical antiseptics incorporating zinc chloride will propel demand.
  • Emerging applications: Potential therapeutic uses in wound healing agents and dermatological treatments could unlock new revenue streams.

Projected Revenue Outlook

By 2030, the revenue generated from pharmaceutical-grade zinc chloride could reach USD 300-350 million, representing a steady CAGR aligned with overall pharmaceutical growth trends. The growth rate may accelerate if zinc chloride gains approval as an active ingredient in specific therapeutic areas or capsular formulations.

Regulatory and Market Entry Considerations

Regulatory approval processes in major markets such as the US, Europe, and Japan heavily influence product adoption. Manufacturers must adhere to Good Manufacturing Practices (GMP), demonstrate safety and efficacy data, and maintain stringent quality control.

Emerging markets offer additional growth avenues, albeit with higher regulatory hurdles and price sensitivity. Building strategic alliances with local distributors and investing in quality assurance can facilitate successful market penetration.

Strategic Opportunities

  • Formulation innovation: Developing combined antiseptic products integrating zinc chloride for enhanced efficacy can attract dermatological and oral health markets.
  • Pipeline expansion: Incorporating zinc chloride into novel drug delivery systems or topical therapeutics can diversify applications.
  • Process optimization: Improving manufacturing efficiency and sustainability can reduce costs and enhance margins.

Risks and Uncertainties

  • Regulatory delays or restrictions may limit market expansion.
  • Raw material price volatility impacts profitability.
  • Market saturation in mature segments could slow growth.
  • Emerging competitors with alternative zinc compounds or novel antiseptic agents could threaten market share.

Conclusion

Zinc chloride's pharmaceutical market trajectory displays steady growth, driven by demand for antiseptics, topical treatments, and its role as an API reagent. While its direct application as a therapeutic agent remains limited, ongoing formulation innovations and regional healthcare expansion underpin its financial prospects. Market players should focus on regulatory compliance, formulation development, and strategic collaborations to harness emerging opportunities.


Key Takeaways

  • Steady CAGR expected: The pharmaceutical zinc chloride market is projected to grow at approximately 4-6% through 2030, reaching USD 300-350 million globally.
  • Demand driven by antiseptic and topical applications: Increasing skin and oral health issues underpin steady demand.
  • Regional growth hotspots: Asia-Pacific dominates, leveraging expanding healthcare infrastructure and manufacturing capacity.
  • Innovation as a growth lever: Novel formulations and use in new therapeutic areas can unlock additional revenue streams.
  • Regulatory and cost considerations: Navigating regulatory landscapes and managing raw material costs are crucial for sustained growth.

FAQs

1. What are the primary pharmaceutical applications of zinc chloride?
Zinc chloride is mainly used as an antiseptic, astringent in topical formulations, and as a reagent in drug synthesis, notably in dermatological and oral health products.

2. How does zinc chloride compare to other zinc salts in pharmaceutical uses?
While zinc sulfate and zinc oxide are more commonly used as dietary supplements and in topical applications, zinc chloride's niche lies in antiseptic properties and as a chemical reagent during drug manufacturing.

3. What are the main markets driving demand for zinc chloride?
The Asia-Pacific region is the largest consumer, propelled by expanding healthcare infrastructure and manufacturing capabilities. Developed markets also contribute through demand for topical antiseptics.

4. What are the challenges faced by zinc chloride in the pharmaceutical sector?
Regulatory hurdles, limited direct therapeutic indications, competition from other zinc salts, and raw material price volatility pose significant challenges.

5. What future trends could influence zinc chloride’s market growth?
Formulation innovation, regulatory approvals for new therapeutic uses, and growth in regional healthcare sectors are expected to shape future demand and revenue flow.


References

[1] Market Research Future. "Zinc Chloride Market Analysis," 2022.

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