How to Source Levobunolol for Pharmaceutical Formulation

Levobunolol (Eye Drops, 0.5%, 0.25%) is classified under Opthalmology. It is therapeutically aligned with reference brands such as Betagan (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Levobunolol for formulation, R&D, or bulk manufacturing.

Product Overview: Levobunolol is a non‑selective beta‑adrenergic blocking agent (beta‑blocker) used to lower intraocular pressure in conditions like glaucoma or ocular hypertension. When applied as eye drops, it decreases production of aqueous humor in the eye, helping to reduce pressure and prevent optic nerve damage. It is generally administered as 1–2 drops in the affected eye(s), often once or twice daily, under ophthalmologist supervision.

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

Levobunolol 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 Levobunolol 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 Levobunolol is more than procurement—it’s a strategic partnership. With its eye drops form and 0.5%, 0.25% 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.

Frequently Asked Questions For Sourcing of Levobunolol