Last updated: July 29, 2025
Overview of Dorzolamide Hydrochloride
Dorzolamide Hydrochloride is a carbonic anhydrase inhibitor primarily used in ophthalmology to treat elevated intraocular pressure in conditions such as glaucoma and ocular hypertension. Marketed typically as a topical ophthalmic solution, its demand is driven by the global rise in glaucoma prevalence and advancements in ophthalmic drug formulations. Identifying reliable suppliers for Dorzolamide Hydrochloride is critical for pharmaceutical manufacturers, compounding pharmacies, and researchers aiming to produce or study this medication.
Global Supply Landscape
The supplier landscape for Dorzolamide Hydrochloride is characterized by a mix of large-scale API (Active Pharmaceutical Ingredient) manufacturers, generic drug producers, and specialty chemical suppliers. These entities operate across multiple regions, notably in China, India, Europe, and North America, providing a comprehensive supply chain for the compound.
Key Suppliers of Dorzolamide Hydrochloride API
1. SAINT-GOBAIN (Sandoz)
Sandoz, a Novartis division, stands out as a leading supplier of generic pharmaceuticals, including APIs like Dorzolamide Hydrochloride. With a robust manufacturing infrastructure and rigorous quality controls, Sandoz supplies pharmaceutical companies globally with high-purity APIs, adhering to regulatory standards such as USP, EP, and JP.
2. Zhejiang Hisoar Pharmaceutical Co., Ltd.
Based in China, Zhejiang Hisoar specializes in the manufacturing of pharmaceutical intermediates and APIs. They have established a reputation for producing Dorzolamide Hydrochloride with consistent quality and competitive pricing, making them a preferred supplier for emerging markets and generic drug manufacturers.
3. Aurobindo Pharma Ltd.
Aurobindo Pharma is an Indian multinational that manufactures a wide array of APIs, including Dorzolamide Hydrochloride. Their facilities comply with international GMP standards, and they possess a significant export footprint, serving clients across North America, Europe, and Asia.
4. Zhejiang Chiral Pharmaceutical Co., Ltd.
This Chinese producer supplies chiral intermediates and APIs, including Dorzolamide Hydrochloride. Their focus on quality assurance and adherence to global regulatory frameworks makes them a notable supplier within the ophthalmic API market.
5. Zhaoke Pharmaceutical (Hefei) Co., Ltd.
Zhaoke is a Chinese biosciences-based pharmaceutical manufacturer that produces both API and finished dosage forms. They emphasize innovation and comply with international quality standards, expanding their role in supplying Dorzolamide Hydrochloride.
Major Commercially Available Brand Names and Suppliers
While Dorzolamide Hydrochloride is often marketed under brand names such as Trusopt (by Novartis), most of the supply for manufacturers and compounding pharmacies comes from API suppliers rather than the finished formulations. The availability of branded products is limited geographically, with generic versions primarily sourced from API producers.
Factors Influencing Supplier Selection
- Regulatory Compliance: Suppliers must adhere to cGMP (current Good Manufacturing Practices) and regulatory standards set by agencies like the FDA, EMA, and MDR.
- Quality Assurance: High purity, consistent batch-to-batch quality, and validated stability profiles.
- Pricing and Lead Time: Competitive pricing, reliable supply chains, and scalable production capacities.
- Market Focus: Suppliers tailored toward large-scale manufacturing versus smaller or niche markets.
- Support and Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory dossiers.
Emerging Trends and Challenges
The sourcing of Dorzolamide Hydrochloride faces challenges including geopolitical trade tensions, stringent regulatory standards, and supply chain disruptions, notably during pandemics. Manufacturers are increasingly prioritizing suppliers with global compliance certifications and robust quality management systems to mitigate risks.
Conclusion
The supply of Dorzolamide Hydrochloride API is concentrated among a handful of reputable manufacturers, predominantly in China and India, with established names such as Zhejiang Hisoar, Aurobindo Pharma, and Zhaoke Pharmaceutical leading the market. Due diligence, including regulatory compliance and quality assurance, remains essential when selecting a supplier to ensure product efficacy and safety.
Key Takeaways
- The main Dorzolamide Hydrochloride API suppliers are Zhejiang Hisoar Pharmaceutical, Aurobindo Pharma, Zhejiang Chiral Pharmaceutical, and Zhaoke Pharmaceutical.
- Quality standards such as cGMP compliance and regulatory certifications are critical for sourcing APIs suitable for pharmaceutical formulations.
- Geopolitical factors and global supply chain disruptions influence sourcing strategies; diversified supplier bases mitigate risks.
- OEM and generic drug manufacturers should prioritize suppliers with proven track records, high purity standards, and comprehensive documentation.
- The future of Dorzolamide Hydrochloride supply depends on regulatory transparency, quality consistency, and supply chain resilience.
FAQs
1. What are the primary regions exporting Dorzolamide Hydrochloride APIs?
China and India are the dominant exporters, with numerous manufacturers providing high-volume, cost-effective APIs to global markets.
2. How can manufacturers verify the quality of Dorzolamide Hydrochloride API from suppliers?
Request Certificates of Analysis, review compliance documentation, and consider third-party testing and audits to verify purity, stability, and regulatory adherence.
3. Are there any patent restrictions on sourcing Dorzolamide Hydrochloride?
Most patents on Dorzolamide Hydrochloride have expired, enabling generic manufacturers to produce the API. However, specific formulations or technologies may still be patent-protected, requiring proper licensing.
4. Which suppliers are most compliant with international regulatory standards?
Leading suppliers such as Aurobindo Pharma and Zhaoke Pharmaceutical operate GMP-compliant facilities recognized by global agencies like the EMA and FDA.
5. What future trends could impact the supply of Dorzolamide Hydrochloride?
Increased regulatory stringency, supply chain diversification, technological advancements in manufacturing, and geopolitical considerations are likely to influence the supply landscape moving forward.
Sources
[1] Pharmaceutical Business Review, "Top API Manufacturers in Asia," 2022.
[2] Novartis, "Trusopt Product Information," 2023.
[3] European Medicines Agency (EMA), "Guidelines for Ophthalmic Pharmaceuticals," 2021.
[4] Company websites: Zhejiang Hisoar, Aurobindo Pharma, Zhejiang Chiral Pharmaceutical, Zhaoke Pharmaceutical.
