Inke specializes in the development and manufacturing of active pharmaceutical ingredients, with a primary focus on respiratory inhalation therapies. In addition to our expertise in respiratory APIs, we also produce high-quality APIs for various other therapeutic areas, ensuring comprehensive solutions to meet diverse medical needs.
| API | Indication | Micronised / PSD | CEP | EU DMF | US DMF | JP DMF | KR DMF | CN DMF | RU DMF |
|---|---|---|---|---|---|---|---|---|---|
| Aclidinium bromide | COPD | • | • | • | |||||
| Arformoterol tartrate (A) | COPD | • | • | • | |||||
| Arformoterol tartrate (D) p | COPD | • | • | • | |||||
| Formoterol fumarate
dihydrate |
Asthma and COPD | • | • | • | • | • | • | • | |
| Glycopyrrolate bromide p | COPD | • | • | • | • | • | • | ||
| Indacaterol acetate | Asthma | ||||||||
| Indacaterol maleate p | Asthma and COPD | • | • | • | • | • | • | ||
| Montelukast sodium p | Asthma, allergic & seasonal rhinitis | • | • | ||||||
| Olodaterol HCl p | COPD | • | • | • | |||||
| Revefenacin trihydrate | COPD | • | • | • | |||||
| Salmeterol xinafoate p | Asthma and COPD | • | • | • | • | • | |||
| Tiotropium bromide
monohydrate |
COPD | • | • | • | • | • | |||
| Umeclidinium bromide | COPD | • | • | • | • | ||||
| Vilanterol trifenatate | Asthma and COPD | • | • | • |
Product Portfolio
Explore our product list below, featuring our extensive range of high-quality APIs across all therapeutic areas. This includes our specialized respiratory APIs as well as APIs for various other medical needs, showcasing our commitment to delivering excellence in pharmaceutical manufacturing.
| 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 dihydrate | 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 trihydrate | COPD | EU-US-CN DMF | ||
| Salmeterol xinafoateP | Asthma and COPD | ✓ | CEP/ US-CN-KR DMF | |
| Tiotropium bromide monohydrate | COPD | ✓ | CEP/US-CN-RU DMF | |
| Umeclidinium bromide | COPD | ✓ | EU-US-CN DMF | |
| Vilanterol trifenatate | 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 | |
| Antihipertensive | CarvedilolP | Hypertension, angina, heart failure | JP DMF | |
| Clevidipine butyrateP | Hypertension | EU-US-CN DMF | ||
| Enalapril maleateP | Hypertension | CEP/KR DMF | ||
| Imidapril | Hypertension | EU DMF | ||
| Nitrendipine | Hypertension | ✓ | CEP/DMF | |
| Antimigrainics | Eletriptan hydrobromideP | Migraine | ✓ | JP DMF |
| Rizatriptan benzoateP | Migraine | ✓ | EU-US 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 | ||
| Quetiapine hemifumarateP | Schizophrenia, psychosis | JP-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
Our dedication to innovation is reflected in our robust pipeline of products under development. These upcoming APIs are designed to address unmet medical needs and provide new therapeutic options for various health conditions.
| THERAPEUTIC AREA | PRODUCT | INDICATION | SAMPLES | TECHNICAL PACKAGE | VALIDATION BATCH | DMF |
|---|---|---|---|---|---|---|
| Antiasthmatics, COPD and respiratory diseases |
Indacaterol acetate | Asthma | ✓ | Q3 2024 | Q3 2024 | Q1 2025 |
| Antiparkinson | Benserazide HCl | Parkinson’s disease | ✓ | ✓ | Q2 2024 | Pending |
| Rotigotine | Parkinson’s disease | ✓ | Q3 2024 | Q4 2024 | Q3 2025 | |
| Other disorders | Tafamidis meglumine | Transthyretin amyloidosis | ✓ | ✓ | ✓ | Q4 2024 |
| Solriamfetol HCl | Narcolepsy | Q2 2024 | Q3 2024 | Q2 2024 | Pending | |
| Prasugrel HCl | Prophylaxis & therapy of thrombosis | ✓ | Q2 2024 | Pending | Pending | |
| Mavacamten | Cardiomyopathy | ✓ | Q2 2024 | Q4 2024 | Q2 2025 |
CEP = Products with Certificate of Suitability
P = Patent applications/granted patents owned by Inke
* = submitted (under evaluation)
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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