Commercialised

√ – Filed,  * Under filing

Product Name DMF/Techpack Bio equivalence established (Y/N) Type of BE study
Fast/Fed
RLD/Mkt Stability Brazil Turkey Mexico MENA APAC
Duloxetine DR Pellets 17% (HPMC Phthalate) Techpack No 6M Yes
Duloxetine HCl DR Pellets 20% (HPMC Acetyl succinate) DMF Yes Fast & Fed CYMBALTA/EU 36M Yes Yes
Duloxetine HCl DR Pellets 20% (HPMC Phthalate) DMF Yes Fast & Fed CYMBALTA/EU 36M Yes Yes
Fenofibrate SR Pellets 75% DMF No 36M Yes Yes
Fenofibric acid DR Pellets 29% DMF No 6M Yes Yes
Itraconazole IR Pellets 21.74% DMF Yes Fast & Fed SPORANOX/US 24M Yes
Itraconazole IR Pellets 22% DMF No 36M Yes Yes Yes
Lansoprazole Pellets 8.5% DMF No * * Customer established BE in TR 36M Yes Yes Yes
Mebeverine HCl IR Pellets 40% DMF No 6M Yes
Mebeverine HCl SR Pellets 72% DMF No 6M
Mebeverine HCl SR Pellets 80% DMF Yes Fast & Fed & MDD/SS COLOFAC MR/ EU 36M Yes Yes
Methylphenidate HCl ER Pellets 11% Techpack Yes Fast & Fed RITALIN LA/BR 3M
Metoprolol SR Pellets 66% DMF No * *Customer established BE in TR 12M Yes
Omeprazole DR Pellets 8.5% (LD-30) DMF No 36M Yes Yes Yes
Omeprazole Pellets 8.5% (Phthalate) DMF No 12M Yes Yes Yes
Orlistat IR Pellets 50% (Extrudes) DMF No 36M Yes
Posaconazole Granules 16.39% Techpack Yes Fast & Fed NOXAFIL/US NA
Tamsulosin ER Pellets 0.12% NA Yes Fast & Fed FLOMAX/US, CAN NA Yes
Tamsulosin HCl ER Pellets 0.2% DMF No * Partner established BE in TR and Mexico 36M Yes Yes Yes
Venlafaxine HCl ER Pellets 33% (Brazil) DMF No 24M Yes
Venlafaxine HCl ER Pellets 33% (Regular composition) DMF No Fast & Fed EFFEXOR/TR 48M Yes Yes
Venlafaxine HCl ER Pellets 33% (Turkey) DMF Yes Fast & Fed & MDD/SS EFFEXOR/EU 6M* Yes

Pipeline

Product   Name DMF/ Techpack Bio equivalence will be available   by Type of BE study Fast/Fed RLD/Mkt Stability
Posaconazole   DR granules 16.39% (Direct compressable) DMF Available Fast & Fed Noxafil Capsules/US 6 M
Dabigatran etexilate SR pellets 35% w/w Tech pack Feb'23 Fast   & Fed PRADAXA/US 6 M
Dexlansoprazole DR pellets 22.5% w/w Tech pack Mar'23 Fast   & Fed DEXILANT/US 3 M
Dipyridamole SR pellets 40% w/w Tech pack Available Fast   & Fed AGGRENOX/US 6 M
Donepezil IR pellets 11.11% w/w Tech pack To   be done Fast NAMZARIC/US 6 M
Esomeprazole DR pellets 22.5% w/w Tech pack Available Fast NEXIUM/EU 12 M
Memantine SR pellets 14 % w/w Tech pack Available Fast   & Fed NAMZARAC/US 6 M
Methylphenidate HCL MR Pellets 11% Tech pack Available Fast   & Fed Ritalin LA 40mg 6 M
Galantamaine SR Pellets 8% w/w Under development Mar'23 Fast   & Fed Reminyl/Razadyne 8mg
Trimetazidine ER granules (Direct compressable) Under development Mar'23 Fast   & Fed Vastarel MR
Levodopa & Benserazide ER granules (for encapsulation) Under development June'24 Fast   & Fed Madopar PR capsules
Levodopa & Benserazide IR granules (for encapsulation) Under development June'24 Fast Madopar Capsules
Levodopa & Benserazide IR granules (Direct compressable) Under development June'24 Fast Madopar Tablets
Desvenlafaxine succinate SR Pellets 41.38% to be initiated PRISTIQ Tablets
Propiverine MR   Pellets to be initiated Detrunorm MR capsules