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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
Amiodarone Anti-arrhythmic 1951-25-3 21694 Y Y
Misoprostol Anti-ulcerant 59122-46-2 21188 Y Y
Oxybutynin HCl Urinary Incontinence 5633-20-5 19447 Y Y
Aprepitant Anti-emetic 170729-80-3 26065 Y  
Irbesartan Anti-hypertensive 138402-11-6 26684 Y  
Trazodone Anti-depressant 19794-93-5 20920 Y  
Acyclovir Anti-viral 59277-89-3 25389 Y  
Valacyclovir Anti-viral 124832-26-4 26546 Y  
Quetiapine Fumarate Anti-depressant 111974-72-2 24816 Y  
Tramadol Analgesic 36282-47-0 24954 Y  
dl-Cloprostenol Sodium* Luteolytic Agent 55028-72-3 15758 Y  
Sulindac NSAID 38194-50-2 26004 Y  
Metaxalone Muscle Relaxant 1 665-48-1 27105 Y  
Mebeverine Anti-spasmodic 2753-45-9   Y  
Monosulfiram Ectoparasiticide 95-05-6   Y  
Perindopril Anti-hypertensive 99149-83-4      
Donepezil Anti-Alzheimer's 142057-77-0      
Pregabalin Anti-convulsant 1 48553-50-8      
Pramipexole Anti-Parkinsons 1 04632-26-0      
Baclofen Muscle relaxant 1134-47-0      
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
CNS Drugs:          
Fosaprepitant Anti-emetic 172673-20-0 Completed Feb-2014 Jun-2014
Others:          
Allopurinol Anti-hyperurecemia 315-30-0 Completed Jan-2014 May-2014
Rosuvastatin Anti-lipemic 287714-41-4 Completed May-2014 Sep-2014
Bisoprolol Fumarate Anti-hypertensive 66722-44-9 Mar-2014 Jun-2014 Oct-2014
Cinacalcet Anti-hyperparathyroid 226256-56-0 Mar-2014 Jul-2014 Nov-2014
Dronedarone Anti-arrythmic 141625-93-6 Mar-2014 Aug-2014 Dec-2014
Prasugruel Anti-platelet 150322-43-3 Mar-2014 Sep-2014 Jan-2015
Raloxifene Anti-osteoporotic 82640-04-8 Mar-2014 Oct-2014 Feb-2015
Entacapone Anti-Parkinson's 130929-57-6 Mar-2014 Nov-2014 Mar-2015


API Intermediates

Available Product Chemical Name CAS No. API
Cis Lactam (2S,3S)-3-Hydroxy-2-(4-methoxyphenyl) 2,3-dihydro-1,
5-benzothiazepin-4(5H)-one
42399-49-5 Diltiazem
HVA (Homo Veratryl Amine) 2-(3,4-Dimethoxyphenyl) Ethyl Amine 120-20-7 Verapamil
KTN-e Cis Imidazole Alcohol 61397-58-8 Ketoconazole
Cis Tosylate Cis-2-(2,4-Dichlorophenyl)-2-(1H-Imidazole-1-yl)
methyl-4-(P-Toluene Sulfonyloxy)methyl-1,3-Dioxalane
134071-44-6

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.