Active pharmaceutical ingredients (APIs)

Explore our comprehensive API portfolio across all therapeutic areas, including current products and development pipeline

At Inke, we specialise in delivering high-quality Active Pharmaceutical Ingredients (APIs)—the very compounds that give medicines their therapeutic power. Whether you’re seeking a partner who can navigate complex synthesis, scale-up efficiently, or meet the stringent regulatory demands of global markets, our API service provides a robust solution. When you search for “active pharmaceutical ingredients APIs”, you want a trusted producer who — beyond simply supplying a molecule — ensures purity, potency and compliance across every batch. At Inke we understand the pressure you face: formulation timelines, cost constraints, regulatory uncertainty and the ever-present risk of delays or quality setbacks. With our API-driven offering, you gain the reliability and flexibility to bring your drug product to market with confidence.

In this section you will learn exactly how our API service at Inke works: from early-stage development of the biologically active substance, through robust manufacturing under GMP conditions, to delivering an ingredient that meets your formulation and regulatory needs. We’ve structured the service to be transparent, responsive and partner-oriented, so that you can focus your energies on advancing the finished product while we take care of the API foundation. Because at Inke, our mission is simple: to enable your medicine’s active core to perform precisely when it matters.

Our Approach to API Development & Manufacturing

At Inke, we begin every partnership by digging deep into the core of active pharmaceutical ingredients (APIs): the biologically active substances that power medicine. From the moment of pharmaceutical research to full commercial-scale drug production process, our team tackles the pain points you face — tight timelines, shifting regulatory demands, global supply-chain risks and the constant pressure to deliver high-quality results. We understand that in the pharma industry, failure to control your API can ripple out into delayed launches, cost overruns and failed regulatory filings. With our two-decades plus expertise, we’ve built a service that addresses that risk head-on.

Product Portfolio

THERAPEUTIC AREA PRODUCT INDICATION API MICRONIZED CEP / DMF
Antiallergics Loratadine P Allergy ✓ JP DMF
Antiasthmatics, COPD and
respiratory diseases		 Aclidinium bromide COPD ✓ EU-US DMF
Arformoterol tartrateP polymorph A and D COPD ✓ US-CN–KR DMF
Formoterol fumarate Asthma and COPD ✓ CEP/US-CN-JP-KR DMF
Glycopyrronium bromideP COPD ✓ CEP/US-CN-KR DMF
Indacaterol maleateP COPD ✓ EU-US-CN-KR DMF
Montelukast sodium Asthma, allergic & seasonal rhinitis EU-JP DMF
Olodaterol HClP COPD EU-US-CN DMF
Revefenacin COPD EU-US-CN DMF
Salmeterol xinafoateP Asthma and COPD ✓ CEP/ US-CN-KR DMF
Tiotropium bromide COPD ✓ CEP/US-CN DMF
Umeclidinium bromide COPD ✓ EU-US-CN DMF
Vilanterol trifenatateP Asthma and COPD ✓ EU-US DMF
Antiemetics Aprepitant Emesis ✓ CEP/US DMF
Granisetron baseP Emesis US DMF
Granisetron HClP Emesis CEP/US-JP-KR DMF
Ondansetron baseP Emesis ✓ EU-US DMF
Ondansetron HClP Emesis ✓ CEP/US DMF
Antihypertensive CarvedilolP Hypertension, angina, heart failure JP DMF
Clevidipine butyrateP Hypertension EU-US-CN DMF
Enalapril maleateP Hypertension CEP/KR DMF
Imidapril Hypertension EU DMF
Antimigrainics Eletriptan hydrobromideP Migraine ✓ JP DMF
ZolmitriptanP Migraine ✓ EU-US DMF
Antiparkinson Tetrabenazine Huntington’s disease chorea and Tardive dyskinesia EU-US DMF
Antipsychotics Asenapine maleateP Schizophrenia and acute mania ✓ JP DMF
OlanzapineP Schizophrenia, psychosis EU-US-KR DMF
RisperidoneP Schizophrenia, psychosis ✓ CEP/US-CN-KR DMF
Antithrombotics Prasugrel baseP Prophylaxis & therapy of thrombosis EU DMF
Rivaroxaban Thrombosis. Stroke CEP /US DMF
Spasmolytic Otilonium bromide Irritable bowel syndrome EU DMF

Pipeline

THERAPEUTIC AREA PRODUCT INDICATION SAMPLES TECHNICAL PACKAGE VALIDATION BATCH DMF
Antiasthmatics, COPD and respiratory diseases Ensifentrine P COPD ✓ Q1 2026 ✓ Q2 2026
Indacaterol acetate Asthma ✓ ✓ ✓ Q1 2026
Roflumilast COPD ✓ Pending Q3 2026 Pending
Antiparkinson
Rotigotine Parkinson’s disease ✓ Q1 2026 Q4 2025 Q3 2026
Other disorders Daprodustat Anemia due to CKD Q4 2025 Q2 2026 Q2 2026 Q4 2026
Daridorexant Insomnia ✓ Q1 2026 Q2 2026 Q4 2026
Mavacamten Cardiomyopathy ✓ Q1 2026 Q1 2026 Q3 2026
Prasugrel HCl Prophylaxis & therapy of thrombosis ✓ Pending Pending Pending
Solriamfetol HCl Narcolepsy ✓ Pending Pending Pending
Tafamidis P Transthyretin amyloidosis ✓ Pending Pending Pending
Tafamidis meglumine Transthyretin amyloidosis ✓ ✓ ✓ Pending

 

Inke Ophthalmics

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

 

Pipeline

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

11CEPs

Granted in Europe

25DMFs

Filed in USA

8DMFs

Filed in Japan

10DMFs

Filed in Korea

14DMFs

Filed in China

We guide you through every phase of your API journey

Whether it’s route scouting, process optimisation, micronisation, or supply-chain integration, we bring clarity and control. From tackling complex chemistries (including micronisation of active compounds, handling hazardous reagents, controlling particle size) to rigorous regulatory compliance and FDA approval readiness, our offering spans the full lifecycle. You’ll explore how we support everything from pre-clinical development up to commercial manufacture, and how we deliver tailored solutions across therapeutic areas including respiratory, ophthalmic, antihypertensives, antipsychotics and beyond. Ready to secure your API foundation?

Therapeutic Focus: Beyond Respiratory APIs

While respiratory therapies remain a core strength at Inke, we place equal emphasis on multiple therapeutic areas to support comprehensive drug pipelines across indications. In our API services you will engage with depth in domains such as central nervous system (CNS) and Ophthalmic HPAPIs. Our position in the pharma industry enables us to adapt complex synthesis, process development, particle engineering, and scale strategies tailored to each therapeutic area, not just each molecule. By mastering disease-area requirements (e.g. stability, dosing, targeting, impurity profiles), we deliver APIs that align seamlessly with formulation and regulatory pathways for diverse clinical programs.

Every therapeutic area brings its own challenges: inhalation APIs require precise particle engineering and consistent aerodynamic performance; CNS APIs demand stringent impurity control and high stability for low-dose formulations; and ophthalmic HPAPIs call for advanced containment and ultra-high purity to ensure patient safety.

At Inke, we’ve built strong internal capabilities across these domains — from complex synthesis to micronisation and high-containment manufacturing — allowing us to approach each project with deep domain expertise. When you partner with Inke, you gain more than an API supplier: you collaborate with a team that understands the specific constraints, delivery systems, and regulatory pathways of your therapeutic area, ensuring your API is optimized for efficacy, safety, and compliance worldwide.

Our Comprehensive Service Offering

Our API service covers the full spectrum — from development to commercial supply. In the pharmaceutical innovation arena, speed and flexibility matter: we streamline the journey from early-stage active compounds through scale-up, tech-transfer and final manufacture. You’ll find we deploy advanced particle engineering (to control size, shape and morphology), robust impurity profiling, solvent residual control, and strict microbiological testing — all integral to the drug substance that underpins your finished product.

More specifically: we begin with process development and route design, tailor a synthesis that suits your molecule’s needs, advance through scale-up in our ISO-7 clean rooms, perform micronisation and particle shaping to optimise for formulation, and continuously validate critical process controls and cleaning protocols. Our supply-chain management ensures continuity and traceability across every batch — an essential factor when working in a regulated environment where regulatory compliance is non-negotiable.

Quality, Compliance & Global Supply Assurance

In the regulated world of the pharma industry, FDA approval, global audits and supply-chain resilience are table stakes. At Inke we treat compliance as a core value — not an afterthought. We operate contained equipment for hazardous chemical handling, perform routine microbiological testing, control amorphous content and residual solvents, and validate cleaning processes throughout. Our manufacturing site is designed for complex chemical reactions and micronisation under ISO-7 conditions — giving you confidence in both small-molecule and high-complexity API production.

Learn more

We understand that the pharmaceutical supply chain is only as strong as its most vulnerable point. That’s why at Inke we design resilience into every stage — from dual-site manufacturing and multi-regional logistics to full transparency and traceability systems. Our robust quality framework and agile operations reduce risk, enhance scalability, and ensure business continuity from development to commercial supply.

FAQs — Active Pharmaceutical Ingredients (APIs)

What therapeutic areas do you cover beyond respiratory?

Inke’s portfolio also covers the Central Nervous System (CNS) and Ophthalmic therapeutic areas, including high-potency APIs (HPAPIs) for glaucoma and ocular hypertension.

How do you ensure regulatory compliance for diverse therapeutic APIs?

We apply stringent FDA approval readiness practices, validate cleaning processes, manage impurities, ensure traceability, and operate under quality systems tailored to each therapeutic domain.

Can you support both small-molecule and complex APIs across these areas?

Yes — we manage complex synthesis, contained equipment, micronization, crystal engineering, and scale-up challenges across both simple and intricate molecules.

Do you provide API support from development through commercial supply?

Absolutely. Our service covers route design, process development, tech transfer, scale-up, manufacturing and support across the lifecycle in multiple therapeutic areas.

Our New Therapeutic Area

Expanding our expertise into ophthalmology with high-potency APIs (HPAPIs) for glaucoma and ocular hypertension — manufactured under the highest containment and quality standards.

Discover Inke Ophthalmics