Under development dossiers
Last update: October 2019
Alimentary Tract & Metabolism
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH |
|---|---|---|
| Dapagliflozin * | Film-coated tablets |
5 mg 10 mg |
| Dapagliflozin* / Metformin | Film-coated tablets |
5/850 mg 5/1000 mg |
| Empagliflozin* | Film-coated tablets |
10 mg 25 mg |
| Linagliptin* / Metformin | Film-coated tablets |
2.5/500 mg 2.5/850 mg 2.5/1000 mg |
Blood & Blood Forming Organs
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH | |
|---|---|---|---|
| Acetylsalicylic Acid | Gastro-resistant coated tablets |
100 mg 300 mg | |
| Dabigatran etexilate (mesylate) * | Capsules |
75 mg 110 mg 150 mg |
Cardiovascular System
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH | |
|---|---|---|---|
| Enalapril | Tablets |
5 mg 10 mg 20 mg | |
| Enalapril / Hydrochlorothiazide* | Tablets |
10/25 mg 20/12.5 mg | |
| Nebivolol* | Tablets |
5 mg 10 mg |
Dermatologicals
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH |
|---|---|---|
| Adapalene / Benzoyl peroxide | Gel | 0.1% + 2.5% |
|
Equisetum arvense extract / Hydroxypropyl chitosan / Biotin | Water-soluble nail lacquer | -- |
Respiratory
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH |
|---|---|---|
| Glycopyrronium | Inhalation powder, hard capsules | 44 mg |
| Indacaterol / Glycopyrronium | Inhalation powder, hard capsules | 85/43 mg |
Oncology
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH |
|---|---|---|
| Lenalidomide | Capsules |
2.5 mg I 5 mg I 7.5 mg 10 mg I 15 mg 20 mg I 25 mg |
Vitamins & Minerals
| PRODUCT NAME | PHARMACEUTICAL FORM | STRENGTH |
|---|---|---|
| Cholecalciferol (Vitamin D3) | Soft gelatin capsules |
20 000 IU 50 000 IU 100 000 IU |
For more information regarding available dossiers, please contact us or download the dossier list with extended information here
Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries.
* Polpharma Group API, (CA) Dossier also available for Canadian market, (*) Stability zone IVb on-going only for strawberry flavour, (**) Dossier update not earlier than Q3 2019, (***) Dossier availability subject to some restrictions
We Offer
High level of customer service
Excellent products with CTD dossiers meeting EU requirements
Regulatory knowledge and expertise
Full support in developing registration strategies
to meet the needs of our customers
Execution and support in registration procedures upon customer’s request
QA service and pharmacovigilance service (PSUR)
Intellectual property expertise
Highly skilled and professional team of Project Managers
Partnership in a win-win strategy