How to Source Brimonidine tartrate + Timolol maleate for Pharmaceutical Formulation
Brimonidine tartrate + Timolol maleate (Eye Drops, 0.2%+0.5%) is classified under Opthalmology. It is therapeutically aligned with reference brands such as Combigan (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Brimonidine tartrate + Timolol maleate for formulation, R&D, or bulk manufacturing.
Product Overview:
Combigan is a fixed-dose combination ophthalmic solution that combines an α₂-adrenergic agonist (brimonidine) with a non-selective β-adrenergic blocker (timolol) to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Brimonidine decreases aqueous humour production and increases uveoscleral outflow, while timolol reduces aqueous humour formation.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Brimonidine tartrate + Timolol maleate must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Brimonidine tartrate + Timolol maleate is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Brimonidine tartrate + Timolol maleate is more than procurement—it’s a strategic partnership. With its eye drops form and 0.2%+0.5% specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Brimonidine tartrate + Timolol maleate.
Frequently Asked Questions For Sourcing of Brimonidine tartrate + Timolol maleate
What is the typical lead time for Brimonidine tartrate + Timolol maleate?
Lead times range from 4–6 weeks depending on supplier and region.
Is Brimonidine tartrate + Timolol maleate available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Brimonidine tartrate + Timolol maleate require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Brimonidine tartrate + Timolol maleate?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Brimonidine tartrate + Timolol maleate?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Brimonidine tartrate + Timolol maleate?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Brimonidine tartrate + Timolol maleate suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Brimonidine tartrate + Timolol maleate be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.