Off-Patent APIs
Pharma Solutions has developed a range of off-patent APIs for global markets. We have a presence in over 63 countries with an established network of distributors in several Asian, Latin American and EU countries. We supply leading Generic and big Pharma companies from our network of internationally compliant manufacturing sites across North America, the UK and India
We develop and commercialize off-patent APIs and supply to our Global customers. We have a product basket of 18 APIs with DMFs & other regulatory filings and a pipeline of about 20 APIs at various stages of development.
We are the leading manufacturers for the following off-patent APIs:
Commercial APIs
| Product | Category | CAS No. | Regulatory Filings | ||
|---|---|---|---|---|---|
| US-DMF # | DMF-CTD | CEP | |||
| Diltiazem | Anti-hypertensive | 42399-41-7 | 14713 |  |
|
| Verapamil | Anti-hypertensive | 52-53-9 | 16605 | |
|
| Ketoconazole | Anti-fungal | 65277-42-1 | 17290 | |
|
| Amiodarone | Anti-arrhythmic | 1951-25-3 | 21694 | |
|
| Oxybutynin Hcl | Urinary Incontinence | 5633-20-5 | 19447 | |
|
| Misoprostol | Anti-ulcerant | 59122-46-2 | 21188 | |
|
| Trazodone | Anti-depressant | 19794-93-5 | 20920 | |
|
| dl-Cloprostenol Sodium* | Luteolytic Agent | 55028-72-3 | 15758 | |
|
| Quetiapine | Anti-depressant | 111974-72-2 | 24816 | |
|
| Tramadol | Analgesic | 36282-47-0 | 24954 | |
|
| Gemfibrozil | Anti-hyperlipidemic | 25812-30-0 | 20437 | |
|
| Acyclovir | Anti-viral | 59277-89-3 | 25389 | |
|
| Aprepitant | Anti-emetic | 170729-80-3 | 26065 | |
|
| Sulindac | NSAID | 38194-50-2 | 26004 | |
|
| Valacyclovir | Anti-viral | 124832-26-4 | |
||
| Mebeverine | Anti-spasmodic | 2753-45-9 | |
||
| Monosulfiram | Ectoparasiticide | 95-05-6 | |
||
| Camylofin | Anti-spasmodic | 5892-41-1 | |||
* Veterinary Drug
APIs Under Development
| Product | Category | CAS No. | Status | ||
|---|---|---|---|---|---|
| Lab Development | Validations | DMF Filing | |||
| Antihypertensives: | |||||
| Irbesartan | Anti-hypertensive | 138402-11-6 | Completed | Completed | Oct-2012 |
| Perindopril | Anti-hypertensive | 99149-83-4 | Completed | Nov-2012 | Mar-2013 |
| CNS Drugs: | |||||
| Donepezil | Anti-Alzheimer's | 142057-77-0 | Completed | Nov-2012 | Mar-2013 |
| Pramipexole | Anti-Parkinsons | 104632-26-0 | Completed | Nov-2012 | Mar-2013 |
| Pregabalin | Anti-convulsant | 148553-50-8 | Completed | Dec-2012 | Apr-2013 |
| Fosaprepitant | Anti-emetic | 172673-20-0 | Mar-2013 | May-2013 | Sep-2013 |
| Others: | |||||
| Allopurinol | Anti-hyperurecemia | 315-30-0 | Completed | Aug-2012 | Dec-2012 |
| Metaxalone | Muscle relaxant | 1665-48-1 | Completed | Sep-2012 | Jan-2013 |
| Emtricitabine | Anti-viral | 145213-48-5 | Completed | Dec-2012 | Apr-2013 |
Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement.
However, the final responsibility, with respect to third party patent rights in a specific country, lies exclusively with the user.