Dorzolamide Hydrochloride API supplier – ultimate guide for bulk buyers
If you are an API buyer, procurement manager, or pharmaceutical purchaser, this guide will help you understand everything about Dorzolamide Hydrochloride API — including its uses, sourcing strategies, supplier evaluation, and regulatory requirements for bulk procurement.
1) What is Dorzolamide Hydrochloride?
Dorzolamide Hydrochloride is the hydrochloride salt form of dorzolamide, widely used in ophthalmic medicines to reduce intraocular pressure in glaucoma and ocular hypertension patients.
- Carbonic anhydrase inhibitor used in eye treatments
- Typically appears as white or off-white crystalline powder
- CAS No: 130693-82-2
- Critical API for ophthalmic formulations
2) Why it is important in pharmaceutical manufacturing
- Key ingredient in glaucoma eye drops
- Ensures therapeutic effectiveness of final formulations
- API quality directly impacts safety and compliance
- High purity ensures global regulatory acceptance
3) Global supplier landscape
Dorzolamide Hydrochloride API is supplied globally by manufacturers across India, China, Europe, and the US. Each region offers different advantages in pricing, compliance, and scalability.
- India: Cost-effective, GMP-compliant manufacturers
- China: High-volume production and competitive pricing
- Europe/US: Strong regulatory approvals like CEP and USDMF
4) How to evaluate API suppliers
A) Compliance and certification
- GMP certification
- USDMF / CEP / EP documentation
- Certificate of Analysis (CoA)
B) API quality and specifications
- Purity ≥99% (HPLC)
- Impurity profile and heavy metal limits
- Batch consistency and validation data
C) Logistics and reliability
- Stable inventory and supply chain
- Flexible packaging options
- On-time delivery and export support
5) Applications in formulation
- Glaucoma eye drop formulations
- Combination therapies (e.g., with timolol)
- Clinical and research formulations
6) Key considerations for bulk buyers
- Match pharmacopeia standards (USP / EP / BP)
- Verify regulatory documentation and DMF availability
- Check stability data and storage conditions
- Plan long-term supply agreements
7) Safety and regulatory notes
Dorzolamide Hydrochloride API is generally safe when used in approved ophthalmic formulations. However, it must be handled under controlled manufacturing conditions and comply with import/export pharmaceutical regulations.
8) Conclusion
Choosing the right Dorzolamide Hydrochloride API supplier ensures consistent quality, regulatory compliance, and reliable supply. For pharmaceutical companies, this directly impacts product success and approval timelines in global markets.
9) Contact us for Dorzolamide API supply
Looking to source Dorzolamide Hydrochloride API in bulk? Contact us for high-quality supply, competitive pricing, and full regulatory support.
Phone: +91 99044 98877 | +91 95580 12935 | +91 91067 95854
Email: mail@globaux.net