Product | Strength | ANDA (Approved/Filed) |
EU Dossier (Approved/Filed) |
ANDS (Approved/Filed) |
Countries for which Dossier are available |
---|---|---|---|---|---|
Baclofen Tablets | 5mg | Approved | Not Filed | Except USA | |
Baclofen Tablets | 10mg | Approved | Not Filed | Except USA | |
Baclofen Tablets | 20mg | Approved | Not Filed | Except USA | |
Cinacalcet tablets | 30 mg | Approved | Approved | Can be offered globally | |
Cinacalcet tablets | 60 mg | Approved | Approved | Can be offered globally | |
Cinacalcet tablets | 90 mg | Approved | Approved | Can be offered globally | |
Doxazosin tablets | 1 mg | Filed | Not filed | Approved in CA | Except USA, Canada |
Doxazosin tablets | 2 mg | Filed | Not filed | Approved in CA | Except USA, Canada |
Doxazosin tablets | 4 mg | Filed | Not filed | Approved in CA | Except USA, Canada |
Entecavir tablets film coated Tablets | 0.5mg | Approved | Approved | Approved in CA | Except CA, SEA, Middle east |
Entecavir tablets film coated Tablets | 1 mg | Approved | Not filed | Except CA, SEA, Middle east | |
Eplerenone Tablets | 25 mg | Filed | Not Filed | Except USA | |
Eplerenone Tablets | 50 mg | Filed | Not Filed | Except USA | |
Esclicarbazepine Tablets | 800 mg | Not filed | Approved | Except USA | |
Itraconazole Capsules | 100 Mg | Approved | Not Filed | Except US, Aus, Canada | |
Mebeverine HCl Tablets | 135 mg | Not filed | Approved | Approved in Aus | Except UK, Aus,Europe |
Mebeverine SR Capsules | 200 mg | Not filed | Approved | Can be offered to USA and ROW | |
Meclizine Tablets | 12.5 mg, 25 mg | Not filed | Not filed | Globally except Aus & New Zealand | |
Metaxalone tablet | 800 mg | Approved | Not Filed | Can be offered globally | |
Methocarbamol Tablets | 500 mg | Approved | Not Filed | Except USA | |
Methocarbamol Film Coated Tablets | 750 mg | Approved | Approved | Except USA, Germany | |
Posaconazole DR Tablets | 100 mg | Filed | Not filed | Except USA, Middle East | |
Propiomazin Tablets | 25 mg | Not filed | Approved | Except Scandivian countries | |
Tamsulosine HCl Capsules | 0.4 mg | Approved | Not Filed | Approved in CA | Can be offered globally |
Tetracycline HCL Capsules | 250 mg | Approved | Not Filed | Except USA | |
Tetracycline HCL Capsules | 500 mg | Approved | Not Filed | Except USA | |
Tolcapone tablets | 100 Mg | Approved | Approved | Except USA and Europe |
Pipeline
Product | Strength | Status |
---|---|---|
FERRIC CITRATE Tablets | EQ210 IRON | Proof of concept established |
Aspirin+Dipyridamole ER Capsules | 25/200mg | Proof of concept established |
Mexiletine Capsules | 150mg/200mg/250mg | Proof of concept established |
Diflunisal tablets | 500 mg | Proof of concept established |
Dipyridamole ER capsules | 200 mg | Proof of concept established |
Solifenacin & Tamsulosin PR tablets | 6 mg/0.4 mg | Proof of concept established |
Hydralazine HCl tablets | 10 mg, 25 mg, 50 mg and 100 mg | Proof of concept established |
Tamsulosin MR tablets | 0.4mg | Under development |
Methylphenidate HCl ER Capsules | 10 mg ,20 mg , 30 mg and 40 mg | Under development |
Dabigatran etexilate Capsules | 75 mg, 110 mg, 150 mg | Under development |
Dexlansoprazole DR capsules | 30 mg and 60 mg | Under development |
Trimetazidine MR Tablets | 35 mg | Under development |
Hydralazine HCl + Isosorbide Dinitrate tablets | 37.5mg/20mg | Under development |
Galantamine ER Capsules | 8mg/16mg/24mg | Under development |
Levodopa + Benserazide Dispersible Tablets | 50mg + 12.5mg, 100mg +25mg | Under development |
Levodopa + Benserazide IR Capsules | 50mg + 12.5mg, 100mg + 25mg, 200mg + 50mg | Under development |
Levodopa + Benserazide IR Tablets | 50mg + 12.5mg, 100mg + 25mg, 200mg + 50mg | Under development |
Levodopa + Benserazide PR Capsules | 100mg + 25mg, 200mg + 50mg | Under development |
Levodopa + Benserazide ER Tablets | 200mg + 50mg | To be initiated |
Trimetazidine IR Tablets | 20 mg | To be initiated |
Nafronyl MR Tabs | 100 mg | To be initiated |
Aripiprazole ODT | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg | To be initiated |
Betahistine tablets | 8mg, 16mg, 24mg | To be initiated |
Fluvoxamine Maleate Tablets | 25 mg, 50 mg, 100 mg | To be initiated |
Fluvoxamine Maleate ER Capsules | 100 mg, 150 mg | To be initiated |
Lamotrigine Dispersible /Chewable tabs | 2mg, 5mg, 25mg,100mg | To be initiated |
Bempedoic Acid Tablets | 180mg | To be initiated |
Lisdexamfetamine dimesylate Capsules | 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, 70mg | To be initiated |