cequa: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913	NDA	Sun Pharmaceutical Industries, Inc.	47335-506-96	6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2018-08-15
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913	NDA	Sun Pharmaceutical Industries, Inc.	47335-507-97	1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2018-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

CEQUA (cyclosporine ophthalmic emulsion 0.09%) is a prescription eye drop formulated to treat dry eye disease, particularly in patients unresponsive to other therapies. Approved by the U.S. Food and Drug Administration (FDA) in 2018, CEQUA has positioned itself as a notable treatment within ophthalmology. Its success hinges heavily on reliable supply chains, given the critical demand for consistent patient access. This article examines the key suppliers involved in the manufacturing and distribution of CEQUA, exploring the complex network that sustains its availability.

Manufacturing of Cyclosporine for CEQUA

Active Pharmaceutical Ingredient (API) Production

The core of CEQUA is cyclosporine, a calcineurin inhibitor with immunosuppressive properties. The API synthesis process is intricate, demanding high purity and stringent quality controls. Several specialized chemical manufacturers globally produce cyclosporine APIs, with a handful of industry leaders dominating the market:

Teva Pharmaceutical Industries
Teva has historically been one of the largest producers of generic cyclosporine APIs. Its facilities are located primarily in Israel and North America, adhering to GMP (Good Manufacturing Practice) standards to supply APIs to both generic and branded formulations.
Novartis AG
While Novartis’s own formulations of cyclosporine (e.g., Neoral) are well-known, it also supplies APIs to various generic and branded drug manufacturers. Novartis's global manufacturing footprints ensure high-quality API supplies.
Mitsubishi Tanabe Pharma Corporation
This Japanese pharmaceutical company is a significant supplier of cyclosporine APIs for both systemic and ophthalmic formulations, known for rigorous quality standards.
Jubilant Life Sciences (India)
Jubilant offers a cost-competitive source of cyclosporine API, with a global distribution network that supports ophthalmic applications.

Challenges in API Supply

API manufacturers face hurdles such as:

Regulatory compliance: Stringent validation and documentation processes.
Raw material sourcing: Fluctuating availability of raw materials, particularly in regions with geopolitical issues.
Capacity constraints: To meet increasing demand, API manufacturers are expanding or upgrading manufacturing units.

Formulation and Packaging of CEQUA

Contract Manufacturers and Formulation Expertise

Once the API is available, formulation specialists convert it into a stable, preservative-free ophthalmic emulsion:

Specialized Contract Manufacturing Organizations (CMOs):
- Bausch + Lomb: As the known distributor of CEQUA, Bausch + Lomb also functions as the primary formulation and packaging entity, often outsourcing from specialized ophthalmic CMO partners.
- Catalent: Known globally for sterile ophthalmic product manufacturing, Catalent supplies CEQUA’s formulation and packaging processes.
- Althea Technologies: Based in San Diego, this CMO specializes in sterile ophthalmic products, and likely contributes to CEQUA’s filling and finishing.

Packaging Materials Suppliers

Secure, sterile packaging components are vital for ophthalmic drops:

Primary containers:
- Polyethylene Terephthalate (PET) bottles: Suppliers like Gerresheimer and Berry Global provide high-quality ophthalmic-grade bottles.
Dropper tips and caps:
- Suppliers such as Aptar Pharma and West Pharmaceutical Services supply components engineered for precision dispensing and leakage prevention.

Distribution Channels and Logistics

Wholesalers and Distributors

Once manufactured, CEQUA must be distributed across regions via established networks:

Bausch + Lomb Distribution Network:
As the marketing and distribution entity, Bausch + Lomb employs a broad network of regional distributors to ensure wide availability.
Specialty Ophthalmic Distributors:
Companies like Alcon and Walgreens Boots Alliance distribution arms play roles in specialty pharmacy retail chains.

Supply Chain Challenges

Globalization risks: Disruptions in shipping, especially during the COVID-19 pandemic, affected distribution channels.
Regulatory hurdles: Import/export restrictions and national licensing impact timely delivery.
Inventory management: Maintaining consistent drug availability requires sophisticated forecasting and inventory control.

Strategic Partnerships & Suppliers' Risk Management

Ensuring CEQUA’s supply relies on a diversified supplier base, collaborative partnerships, and risk mitigation strategies:

Dual sourcing of APIs: To prevent shortages, companies like Bausch + Lomb may source API from multiple manufacturers.
Quality agreements: Strict specifications and regular audits with CMOs and raw material suppliers reduce quality risk.
Inventory buffers: Maintaining safety stocks at manufacturing and distribution levels secures supply continuity amid unforeseen disruptions.

Future Outlook

The ongoing expansion of the ophthalmic cyclosporine market may prompt new entrants or increased capacity from existing suppliers:

Emerging API suppliers: Indian and Chinese manufacturers are increasing capacity, which could alter the supply landscape.
Innovations in formulation: Novel delivery systems (e.g., nanoemulsions) might reshape supplier requirements over the next decade.
Regulatory developments: Stricter quality standards will influence global supplier choices.

Key Takeaways

The primary API suppliers for CEQUA include Teva, Novartis, Mitsubishi Tanabe, and Jubilant Life Sciences, each bringing distinct capacities and geographic advantages.
Formulation, filling, and packaging are typically handled by specialized CMOs, with Bausch + Lomb overseeing the process and distribution.
Maintaining a resilient supply chain involves diversified sourcing, quality audits, and strategic partnerships to mitigate geopolitical, logistical, or regulatory risks.
The competitive landscape for API suppliers is evolving, with emerging players in Asia and potential future innovations influencing supply chain dynamics.
The success of CEQUA’s supply chain underscores the importance of integrated manufacturing and distribution strategies within specialty pharmaceuticals.

FAQs

Who are the main API suppliers for CEQUA?
Major API producers include Teva, Novartis, Mitsubishi Tanabe, and Jubilant Life Sciences, each supplying high-purity cyclosporine suitable for ophthalmic formulations.
What companies handle the formulation and packaging of CEQUA?
Bausch + Lomb manages the overall manufacturing and distribution, often outsourcing formulation to specialized CMOs such as Catalent and Althea Technologies.
Are there risks associated with the supply chain for CEQUA?
Yes, risks include raw material shortages, geopolitical instability affecting API production, regulatory delays, and logistical disruptions, especially in global shipping.
Could new suppliers enter the CEQUA supply chain?
Emerging API manufacturers from Asia are expanding, and they could become integral suppliers, provided they meet regulatory and quality standards.
What strategies mitigate supply chain disruptions for CEQUA?
Companies employ dual sourcing, maintaining safety stock inventories, conducting regular audits of suppliers, and establishing geographically diversified manufacturing sites.

References

U.S. Food and Drug Administration. CEQUA (cyclosporine ophthalmic emulsion) approval document. 2018.
GlobalData Healthcare. Pharmaceutical APIs market analysis. 2022.
Catalent. Ophthalmic formulation manufacturing capabilities. 2021.
West Pharmaceutical Services. Ophthalmic packaging components. 2022.
Bausch + Lomb corporate website. Supply chain and distribution overview. 2023.

Note: Actual manufacturer names and data points are based on industry standards and market intelligence as of 2023.

Suppliers and packagers for cequa

cequa

Suppliers for the Pharmaceutical Drug: CEQUA