ZINC ACETATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eton	GALZIN	zinc acetate	CAPSULE;ORAL	020458	NDA	Teva Pharmaceuticals USA, Inc.	57844-208-52	250 CAPSULE in 1 BOTTLE (57844-208-52)	1997-03-03
Eton	GALZIN	zinc acetate	CAPSULE;ORAL	020458	NDA	Teva Pharmaceuticals USA, Inc.	57844-215-52	250 CAPSULE in 1 BOTTLE (57844-215-52)	1997-03-03
Eton	GALZIN	zinc acetate	CAPSULE;ORAL	020458	NDA	Eton Pharmaceuticals, Inc.	71863-124-25	250 CAPSULE, GELATIN COATED in 1 BOTTLE (71863-124-25)	2025-03-03
Eton	GALZIN	zinc acetate	CAPSULE;ORAL	020458	NDA	Eton Pharmaceuticals, Inc.	71863-125-25	250 CAPSULE, GELATIN COATED in 1 BOTTLE (71863-125-25)	2025-03-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Zinc acetate is a vital inorganic compound with widespread pharmaceutical applications, primarily used in dietary supplements, ophthalmic formulations, and treatments for conditions such as Wilson’s disease. As global demand grows driven by increasing health awareness and therapeutic applications, identifying reliable suppliers of pharmaceutical-grade zinc acetate becomes critical for pharmaceutical manufacturers, distributors, and healthcare providers.

This report provides an in-depth analysis of key suppliers for zinc acetate, considering factors such as product quality, regulatory compliance, supply capacity, geographic distribution, and market reputation. The intention is to equip decision-makers with comprehensive data to inform procurement strategies and ensure a steady, compliant source of this essential compound.

1. Overview of Pharmaceutical-Grade Zinc Acetate

Pharmaceutical-grade zinc acetate demands high purity levels, typically greater than 99%, verified through rigorous quality assurance protocols to meet standards set by agencies such as the US Pharmacopeia (USP), European Pharmacopoeia, or other pharmacopeial standards. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP) and possess robust supply chains to ensure consistent delivery.

2. Major Suppliers of Zinc Acetate for Pharmaceutical Use

A. Bal Pharmaceutical Ltd.

Overview: Based in India, Bal Pharmaceutical is a recognized global supplier specializing in pharmaceutical and nutraceutical ingredients, including zinc acetate.
Product Quality: Offers zinc acetate conforming to USP and other pharmacopeial standards with a purity exceeding 99%. Their products undergo rigorous QC testing.
Regulatory Compliance: Certified under ISO 9001 and GMP; exports to numerous countries including North America, Europe, and Asia.
Supply Capacity: Large-scale production facility with an annual output capacity in the multi-metric ton range, capable of fulfilling both bulk and smaller orders.
Market Reputation: Well-regarded for cost competitiveness and consistent quality, supported by long-standing client relationships.

B. Sinopharm Chemical Reagent Co., Ltd.

Overview: Headquartered in China, Sinopharm is among Asia's largest pharmaceutical ingredient suppliers, offering a comprehensive portfolio including high-grade zinc acetate.
Product Quality: Supplies pharmaceutical-grade zinc acetate meeting USP and Chinese Pharmacopoeia standards; rigorous QC measures are standard.
Regulatory Compliance: Holds GMP certifications and complies with international quality standards, facilitating global distribution.
Supply Capacity: Extensive manufacturing infrastructure capable of large-volume exports; well-placed to meet global demand fluctuations.
Market Reputation: Known for manufacturing reliability, competitive pricing, and efficient logistics.

C. Sigma-Aldrich (Merck Group)

Overview: A leading multinational provider of research chemicals and pharmaceutical ingredients, Sigma-Aldrich supplies high-purity zinc acetate suitable for clinical and manufacturing purposes.
Product Quality: Supplies zinc acetate with certifiable high purity (>99%) meeting regulatory standards like USP and EP.
Regulatory Compliance: Complies with strict GMP and ISO standards; all products are characterized with comprehensive documentation.
Supply Capacity: Global distribution network ensures stable and timely supply to pharmaceutical clients.
Market Reputation: Recognized for premium quality and trusted for research and pharmaceutical applications.

D. Zhejiang Xingyu Pharmaceutical Co., Ltd.

Overview: A Chinese pharmaceutical manufacturer specializing in inorganic compounds including zinc-based products.
Product Quality: Provides zinc acetate with high purity and conforming to international pharmacopeial standards.
Regulatory Compliance: Certified under GMP and ISO; products are suitable for pharmaceutical formulations.
Supply Capacity: Focused on export markets with a stable supply chain and capacity.
Market Reputation: Emerging player with competitive pricing, growing global footprint.

E. American Elements

Overview: US-based provider specializing in high-purity inorganic materials for pharmaceutical, industrial, and research applications.
Product Quality: Offers pharmaceutical-grade zinc acetate with >99% purity, supported by extensive quality documentation.
Regulatory Compliance: Adheres to cGMP, ISO 9001, and other regulatory standards.
Supply Capacity: Small to medium production scale but sufficient for specialty pharmaceutical needs and research.
Market Reputation: Known for premium products and customization services.

3. Factors Influencing Supplier Selection

Regulatory Compliance: Ensuring suppliers meet regional and international standards (FDA, EMA, USP, EP).
Quality Assurance: Access to Certificates of Analysis (CoA), GMP certification, stability data, and purity verification.
Supply Continuity: Suppliers with scalable capacity and reliable logistics to minimize shortages.
Pricing Strategy: Balancing cost-effectiveness with quality standards to optimize procurement budgets.
Geographical Location: Proximity to manufacturing facilities or key markets may influence shipping costs and lead times.
Reputation and Reviews: Past customer feedback regarding consistency, responsiveness, and compliance.

4. Emerging Trends and Considerations

The rise of regional manufacturing hubs in Asia and Eastern Europe has increased options for sourcing zinc acetate.
Growing emphasis on supply chain transparency and quality documentation aligns with global regulatory trends.
Consolidation within the pharmaceutical ingredient industry may influence supplier bargaining power and market dynamics.
Sustainability practices are increasingly significant, with some suppliers adopting greener manufacturing processes.

5. Challenges in Sourcing Zinc Acetate

Regulatory Hurdles: Variations in regional standards necessitate thorough vetting of supplier compliance.
Supply Disruptions: Global supply chain disruptions, such as those seen during pandemics, can affect availability.
Quality Variability: Ensuring batch-to-batch consistency remains critical, emphasizing the importance of quality certifications.
Price Volatility: Fluctuations in raw material prices can impact procurement costs, requiring strategic sourcing.

Concluding Remarks

Sourcing pharmaceutical-grade zinc acetate demands careful evaluation of supplier credentials, compliance, and capacity to meet quality and quantity demands. Leading global suppliers like Bal Pharmaceutical, Sinopharm, and Sigma-Aldrich offer reliable options with established quality standards, while emerging manufacturers expand options for localized procurement. Strategic partnerships and thorough vetting are essential to ensure consistent supply, regulatory adherence, and cost efficiency.

Key Takeaways

Prioritize certified suppliers: Ensure compliance with GMP, USP, EP, or similar standards for safety and efficacy.
Evaluate supply capacity: Select suppliers with scalable and reliable manufacturing to avoid disruptions.
Verify quality documentation: Certificates of Analysis and regulatory certifications are vital.
Consider geographic factors: Balance costs and logistics efficiency based on location.
Monitor market trends: Stay informed on industry developments affecting supply stability and pricing.

FAQs

1. What are the primary pharmaceutical applications of zinc acetate?
Zinc acetate is mainly used as a dietary supplement for zinc deficiency, in ophthalmic formulations like eye drops for herpes keratitis, and in treatments for Wilson's disease, facilitating zinc's role in metal regulation therapy.

2. How do I verify if a zinc acetate supplier adheres to quality standards?
Request and review Certificates of Analysis, GMP certifications, and compliance documentation. Prefer suppliers with recognized certifications such as USP, EP, ISO, and GMP accreditation.

3. What should be considered regarding the purity levels of zinc acetate?
Pharmaceutical-grade zinc acetate typically exceeds 99% purity. Higher purity levels reduce impurity risks, ensuring safety and formulation stability.

4. Are regional suppliers suitable for global pharmaceutical manufacturing?
Yes, but evaluation of their GMP compliance, quality assurance protocols, and logistical capabilities is essential to ensure adherence to international standards.

5. How can supply chain disruptions be mitigated?
Establish multiple supplier relationships, maintain adequate stock levels, and choose suppliers with proven logistical reliability to minimize risks associated with raw material shortages.

Sources

[1] U.S. Pharmacopeia. Zinc Acetate Monograph.
[2] European Pharmacopoeia. Zinc Acetate Specifications.
[3] Bal Pharmaceutical Official Website. Product Data Sheets.
[4] Sinopharm Chemical Reagent Co., Ltd. Product Catalog.
[5] Sigma-Aldrich. Zinc Acetate Material Data Sheet.

Suppliers and packagers for generic pharmaceutical drug: ZINC ACETATE

ZINC ACETATE

Suppliers for the Pharmaceutical Drug: Zinc Acetate

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