√ – 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 |