Suppliers and packagers for latisse

latisse

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-05	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-05) / 5 mL in 1 BOTTLE, DROPPER	2009-01-26
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-70	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-70) / 3 mL in 1 BOTTLE, DROPPER	2009-01-26
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-71	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-71) / 3 mL in 1 BOTTLE, DROPPER	2009-01-26

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Latisse

Introduction

Latisse, a branded treatment formulated for eyelash enhancement, is a prescription medication that gained significant market traction since its approval by the FDA in 2008. Originally marketed as a glaucoma treatment under the generic name bimatoprost, it was repurposed for cosmetic use specifically to grow eyelashes. Its success depended on a reliable supply chain comprising manufacturing suppliers, distributors, and authorized pharmacies. This report details the key suppliers, manufacturing dynamics, and market considerations for Latisse, providing actionable insights for stakeholders engaged in pharmaceutical sourcing and distribution.

Latisse: Overview and Market Position

Latisse, developed by Allergan (now part of AbbVie), is a topical solution containing 0.03% bimatoprost. As a specialized cosmetic product categorized under prescription therapies, it commands a niche but lucrative market segment focused on eyelash growth enhancement. The product’s patent protection and exclusive marketing rights have historically limited the variety of authorized suppliers involved directly with the end product.

Manufacturing and Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

The raw material at the core of Latisse is bimatoprost, a prostaglandin analog. Major manufacturers of bimatoprost supply the active ingredient to authorized pharmaceutical and cosmetic formulators. Key players include:

• Sandoz (Novartis) – Historically a prominent supplier of bimatoprost API, Sandoz's extensive manufacturing capabilities and strict quality controls make it a primary source for generic concentrations.
• LG Life Sciences (South Korea) – A significant exporter of bimatoprost, providing quality APIs suitable for ophthalmic and cosmetic formulations.
• Glenmark Pharmaceuticals – An emerging supplier in the prostaglandin analog space, with capacity to supply high-grade raw materials for both prescription and OTC markets.

Excipients and Formulation Ingredients

The formulation's stability and bioavailability depend on excipients such as benzalkonium chloride (a preservative), sodium chloride, and water for injection. Suppliers of these excipients include:

• Ashland Inc. – Produces a broad portfolio of ophthalmic excipients with compliance to regulatory standards.
• Hymex (Catalent) – Supplies specific ophthalmic-grade preservatives and stabilizers aligned with pharmaceutical specifications.

Manufacturing of Latisse: Contract and In-house Production

Allergan historically maintained an integrated manufacturing approach, but external contract manufacturing organizations (CMOs) have played a pivotal role.

• Catalent Inc. – Known for contract manufacturing and packaging of ophthalmic drugs, Catalent has been involved in the production of Latisse, ensuring dosage accuracy and sterility.
• Patheon (now part of Thermo Fisher Scientific) – Provided formulations and fill-finish services for ophthalmic solutions, supporting supply chain flexibility.

Distribution and Authorized Supply Chains

Latisse distribution involves authorized pharmacies, specialty clinics, and dermatology practices. As a prescription treatment, the supply chain is tightly controlled through:

• Wholesalers and Distributors – Cardinal Health and McKesson serve as primary distributors for licensed pharmacies and clinics in North America.
• Pharmacy Chains – Large pharmacy chains such as CVS, Walgreens, and independent ophthalmic pharmacies procure Latisse directly through authorized distribution channels.

Regulatory and Quality Considerations

Supply chain security for Latisse hinges on compliance with regulatory standards established by the FDA, EMA, and other global agencies. Manufacturers and suppliers must adhere to Good Manufacturing Practices (GMP) to ensure product integrity.

• FDA Inspection Reports – Regular inspection of manufacturing sites is mandatory, validating supplier compliance scores.
• Certificate of Suitability (CEP) – Suppliers of APIs such as bimatoprost often possess CEPs from the EDQM, ensuring raw material quality.

Market Dynamics Impacting Suppliers

The expiration of certain patents and regulatory approvals for generic bimatoprost formulations has increased competition, pressuring brand suppliers to secure exclusive supply deals. Moreover, the rise of counterfeit products portends risk, necessitating stringent supplier vetting processes.

Emerging Trends and Future Supply Chain Considerations

• Diversification of API Sources – Manufacturers and brand owners are exploring alternate suppliers in Asia to mitigate risks associated with geopolitical and supply disruptions.
• Biotechnological Advances – Potential biosimilar developments could alter the landscape, introducing new suppliers into the market.
• Regulatory Harmonization – Global shifts toward stricter quality standards may impact supplier qualification and approval processes, influencing supply chain robustness.

Conclusion

The supply chain for Latisse involves a complex network of API providers, formulation manufacturers, and distribution channels. Key suppliers such as Sandoz, LG Life Sciences, and contract manufacturers like Catalent underpin its production. Ensuring supplier compliance with regulatory standards and managing geopolitical risks are paramount for continued market stability. Businesses engaging in the procurement or distribution of Latisse must maintain rigorous supplier due diligence, adapt to competitive pressures, and monitor emerging technological trends to secure a reliable, quality-driven supply.

---

Key Takeaways

• API Suppliers: Primary sources include Sandoz, LG Life Sciences, and Glenmark Pharmaceuticals, offering quality bimatoprost suitable for ophthalmic and cosmetic uses.
• Formulation and Packaging: Contract manufacturers such as Catalent and Patheon predominantly handle the manufacturing, ensuring GMP compliance.
• Distribution Channels: Strictly controlled through authorized wholesalers and pharmacies to prevent counterfeits and ensure product integrity.
• Market Risks: Patent expirations, geopolitical factors, and regulatory changes influence supplier stability and pricing.
• Strategic Recommendations: Diversify supplier base, monitor regulatory developments, and implement rigorous vetting protocols to mitigate supply chain risks.

---

FAQs

1. Who are the main manufacturers of the API used in Latisse?
   Sandoz (Novartis), LG Life Sciences, and Glenmark Pharmaceuticals are leading API producers for bimatoprost, the active ingredient in Latisse.

2. Are there multiple sources for Latisse’s formulation manufacturing?
   Yes. Contract manufacturers like Catalent and Patheon produce Latisse under strict GMP standards, supporting supply stability.

3. How is the supply chain for Latisse regulated?
   Regulatory agencies such as the FDA oversee manufacturing standards, requiring compliance with GMP, regular inspections, and proper licensing of suppliers.

4. Can generic bimatoprost be used as an alternative to Latisse?
   Yes, but only under strict medical supervision and with a prescription, as off-label or compounded versions may not meet the safety and quality standards of branded Latisse.

5. What risks should businesses consider in sourcing Latisse?
   Risks include supply disruptions, counterfeit products, regulatory non-compliance, and geopolitical influences affecting API availability. Implementing thorough supplier audits mitigates these risks.

---

Sources:

[1] FDA. "Latisse (bimatoprost ophthalmic solution)." U.S. Food and Drug Administration, 2008.
[2] Novartis. "Sandoz Bimatoprost API Overview." 2022.
[3] EDQM. "Certificate of Suitability for Bimatoprost." European Directorate for the Quality of Medicines & HealthCare.
[4] Catalent. "Pharmaceutical Manufacturing Capabilities." 2021.
[5] Statista. "Global ophthalmic drug market." 2022.