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Off-Patent APIs

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 Y Y
Verapamil Anti-hypertensive 52-53-9 16605 Y Y
Ketoconazole Anti-fungal 65277-42-1 17290 Y Y
Misoprostol Anti-ulcerant 59122-46-2 21188 Y Y
dl-Cloprostenol Sodium* Luteolytic Agent 55028-72-3 15758 Y  
Amiodarone Anti-arrhythmic 1951-25-3 21694 Y Y
Trazodone Anti-depressant 19794-93-5 20920 Y  
Aprepitant Anti-emetic 170729-80-3 26065 Y  
Valacyclovir Anti-viral 124832-26-4 26546 Y  
Mebeverine Anti-spasmodic 2753-45-9   Y  
Monosulfiram Ectoparasiticide 95-05-6   Y  
Baclofen Muscle relaxant 1134-47-0   Y *
Perindopril Anti-hypertensive 99149-83-4     *
Pramipexole Anti-Parkinsons 104632-26-0     *
Camylofin Anti-spasmodic 5892-41-1      

* Veterinary Drug
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.



APIs Under Development

Product Category CAS No. Status
Lab Development Validations DMF Filing
Entacapone Anti-Parkinson's 130929-57-6 Completed Oct-2014 Jan-2015
Bisoprolol Fumarate Anti-hypertensive 66722-44-9 Completed Oct-2014 Feb-2015
Cinacalcet Anti-hyperparathyroid 226256-56-0 Completed Nov-2014 Feb-2015
Lurasidone Anti-psychotic 367514-87-2 Completed Dec-2014 Mar-2015
Clobazam Anti-convulsant 22316-47-8 Completed Dec-2014 Mar-2015
Dronedarone Anti-arrythmic 141625-93-6 Completed Mar-2015 Jun-2015
Raloxifene Anti-osteoporotic 82640-04-8 Completed May-2015 Aug-2015
Fosaprepitant Anti-emetic 172673-20-0 Completed    


New APIs Under Consideration for Development

Product Category CAS No. Status
Lab Development Validations DMF Filing
Armodafinil Cerebral Activator 112111-43-0 Apr-2015 Sep-2015 Dec-2015
Nebivolol Anti-hypertensive 99200-09-6 May-2015 Oct-2015 Jan-2016
Ezetimibe Anti-cholesterol 163222-33-1 Jun-2015 Nov-2015 Feb-2016
Lercanidipine Anti-hypertensive 100427-26-7 Jul-2015 Dec-2015 Mar-2016
Dabigatran Anti-coagulant (oral) 211915-06-9 Sep-2015 Feb-2016 May-2016
Paliperidone Palmitate Anti-psychotic 144598-75-4 Nov-2015 Apr-2016 Jul-2016
Atazanavir Anti-viral 198904-31-3 Jan-2016 Jun-2016 Sep-2016
Silodosin Benign Prostatic Hyperplasia (BPH) 160970-54-7 Mar-2016 Aug-2016 Nov-2016
Rufinamide Anti-epileptic 106308-44-5 May-2016 Oct-2016 Jan-2017
Ivabradine Anti-anginal 155974-00-8 Jul-2016 Dec-2016 Mar-2017
Ticagrelor Anti-platelet 274693-27-5 Sep-2016 Feb-2017 May-2017

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.