Inke Ophthalmics

Expanding our expertise into Ophthalmology with Highly Potent APIs for Glaucoma and Ocular Hypertension

Inke Ophthalmics marks a strategic milestone in our growth journey. At Inke, we have expanded our expertise into the ophthalmology segment with a state-of-the-art facility specialized in high-potency ophthalmic APIs. This move strengthens our position as a trusted partner for complex APIs worldwide and reinforces our commitment to innovation, regulatory excellence, and patient safety.

We offer deep technical knowledge in ophthalmic HPAPIs and a strong operational base, enabling us to deliver advanced solutions for the treatment of glaucoma and ocular hypertension, two of the most critical eye conditions globally.

Glaucoma: Facing a Global Challenge

Glaucoma is the second leading cause of irreversible blindness worldwide, affecting more than 80 million people and continuing to rise as populations age. Prostaglandin analogues remain the gold standard for reducing intraocular pressure and are essential in first-line therapies for glaucoma and ocular hypertension.

At Inke Ophthalmics, we provide HPAPIs manufactured under EU-GMP and ANVISA certifications, ensuring global compliance, safety, and efficacy. Our portfolio includes leading prostaglandin analogues such as Latanoprost, Travoprost, Bimatoprost, Tafluprost, and innovative molecules in development.

Interested in our ophthalmic APIs?

High-Containment Manufacturing Excellence

Advanced Containment for Ophthalmic HPAPIs

Our ophthalmic APIs are manufactured in a fully integrated HPAPI facility designed for OEB4 containment according to SafeBridge standards, ensuring maximum operator safety and product integrity. Using isolator technology, we handle highly potent substances under controlled conditions, minimizing exposure and meeting international quality standards.

This advanced containment approach supports full cGMP production, complemented by global major authorities certifications. Combined with rigorous quality systems, these capabilities make Inke Ophthalmics a trusted HPAPI manufacturer.

Ophthalmic Portfolio - HPAPI

Our commercial portfolio includes highly potent prostaglandin analogues for the treatment of glaucoma and ocular hypertension. These APIs are available with full regulatory support and tailor-made services:

API Name CAS Number Therapeutic Use Regulatory Status
Bimatoprost 155206-00-1 Glaucoma / Ocular Hypertension ASMF
Latanoprost 130209-82-4 Glaucoma / Ocular Hypertension CEP, USDMF
Tafluprost 209860-87-7 Glaucoma / Ocular Hypertension ASMF
Travoprost 157283-68-6 Glaucoma / Ocular Hypertension USDMF

 

Pipeline

In addition to our established portfolio, we are actively developing next-generation prostaglandin analogues for first-line glaucoma therapies. These molecules are currently available as laboratory samples for research purposes, reflecting our commitment to innovation and future therapeutic solutions.

API Name CAS Number Therapeutic Use Regulatory Status
Bimatoprost Grenod 1194396-71-8 Glaucoma / Ocular Hypertension Lab Samples
Latanoprostene Bunod 860005-21-6 Glaucoma / Ocular Hypertension Lab Samples

CEP = Products with Certificate of Suitability
P = Patent applications/granted patents owned by Inke

Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorization. In particular these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, i.e. activities carried out to obtain a Marketing Authorization. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

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From Development to Commercial Scale

Integrated R&D and Analytical Expertise

Our ophthalmic HPAPI facility goes beyond manufacturing—it is a fully integrated platform combining R&D, analytical laboratories, and high-containment production areas. This setup allows us to manage complex synthesis processes and purification steps under strict cGMP conditions, ensuring seamless technology transfer and scalability.

We support projects from milligram-scale development to commercial quantities, leveraging advanced equipment such as chromatographic purification systems, isolator-based reactors, and high-precision analytical tools (HPLC, GC, UPLC). This integration guarantees delivering reliable APIs worldwide, reducing time-to-market for ophthalmic therapies while maintaining the highest safety and quality benchmarks.

Advanced Purification Technologies

Chromatographic Purification for Maximum Purity

We employ liquid and supercritical chromatographic purification under GMP conditions to achieve exceptional purity for prostaglandin analogues. These advanced techniques allow precise separation of impurities and ensure compliance with USP and EP standards.
Our purification processes are designed for high-potency APIs, guaranteeing quality, reproducibility, and patient safety in every batch.

Why Leading Pharmaceutical Companies Trust Inke Ophthalmics

OEB4 High-Containment Design

SafeBridge-certified isolator systems for maximum operator safety and product integrity.

Isolator-Based Manufacturing

Controlled synthesis and dispensing for highly potent APIs under strict cGMP conditions.

Chromatographic Purification

Liquid and supercritical processes, ensuring exceptional purity and adherence to the US and Europe Pharmacopoeia standards.

Integrated R&D and Scale-Up

Scalable production across all quantities, with seamless technology transfer and analytical support.

ISO 8 Clean Rooms

High-containment environments for critical operations and global regulatory compliance.

Driving Innovation in Ophthalmic APIs

Committed to Sustainable Manufacturing

We are transitioning to supercritical fluid chromatography (SFC) to reduce solvent use and environmental impact while improving efficiency. Partner with Inke Ophthalmics for greener processes and high-quality APIs for glaucoma therapies.

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