Product
APIs with DMF / COS or European Registered Drug Dossiers are suitably indicated in brackets. [Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement. The liability of any sale into such protected markets is at buyer’s risk.]
| Regular APIs | ||||||
| PRODUCT NAME | PHARMACOPOEIA | Regulatory Approvals Status | REGULATORY APPROVAL | THERAPEUTIC CLASS | ||
| USDMF | CEP/EDMF | Others | ||||
| Atropine Sulfate | USP, EP | #29605 | CEP | China & Australia | CEP EU GMP | Mydriatic and cycloplegic |
| Chlorzoxazone | *eCTD ready (#033920) | |||||
| Clopidogrel Besylate (in tie up with Pharmathen) | IHS | EDMF | GMP | Antiplatelet | ||
| Dex Rabeprazole | IHS | ®EDMF ready | GMP | Proton pump inhibitor | ||
| Dexketoprofen Trometamol | IHS | *eCTD ready (#26959) | EDMF | Russia & MFDS (Korea) | GMP, MFDS | Analgesic |
| Diethyl Carbamazine Citrate | USP, EP | *eCTD ready (#26954) | WHO | EU GMP, WHO | Anthelmintic | |
| Febuxostat (in tie up with Pharmathen) | IHS | ®EDMF ready | GMP | Xanthine oxidase inhibitor | ||
| Homatropine Hydro Bromide | BP, USP, EP | ®EDMF ready | GMP | Anticholinergic medication Mydriatic and cycloplegic | ||
| Homatropine Methyl Bromide | BP, USP, EP | #23963 | EDMF | ANVISA | EU GMP, USFDA | Anticholinergic medication Mydriatic and cycloplegic |
| Ketorolac Tromethamine | EP, USP | EDMF | Russia, MFDS (Korea) & ANVISA | GMP | Analgesic | |
| Levofloxacin Hemihydrate | USP, JP, IHS,EP | ®EDMF ready | EUGMP | Broad Spectrum Antibiotic | ||
| Loxoprofen Sodium | JP | $JDMF filed | GMP | Non-steroidal anti-inflammatory drug, or NSAID | ||
| Nitisinone | IHS | US DMF is prepared (in Feb-2021) | ®EDMF ready | 4-hydroxyphenylpyruvate dioxygenase | ||
| Obidoxime Hydrochloride | EDMF will be ready by Mar-2021 | Antidote: Cholinesterase reactivator | ||||
| Papaverine HCL | US DMF will be ready by Apr-2021 | China DMF will be ready by Apr-2021 | ||||
| Pregabalin (in tie up with Pharmathen) | IHS | EDMF | GMP | Anticonvulsant drug | ||
| Rebamipide | JP | $JDMF filed | GMP | Treatment of gastric Ulcers | ||
| APIs Launching | ||||||
| PRODUCT NAME | PHARMACOPOEIA | Regulatory Approvals Status | REGULATORY APPROVAL | THERAPEUTIC CLASS | ||
| USDMF | CEP/EDMF | Others | ||||
| Carglumic Acid | US DMF will be ready by Dec-2021 | |||||
| Clopidogrel Bisulfate (Form II) | USP | EDMF will be ready by Dec-21 | ||||
| Fursultiamine HCl | ||||||
| Ipratropium bromide | USP, EP | US DMF will be ready by Sep-2021 | EDMF will be ready by Sep-2021 | Bronchodilator | ||
| Ketoprofen | EP, USP | EDMF will be ready by Aug-2021 | GMP | Non-steroidal anti-inflammatory drug, or NSAID | ||
| Intermediates | ||||||
| 1-(2-Ethoxyethyl)-1,3-Dihydrobenzoimidazol-2-One | ||||||
| Acetoxy Ethyl Bromide | ||||||
| Alpha-Methyl Cinnamic Aldehyde | ||||||
| BMC | ||||||
| Bromo Butryric Acid | ||||||
| Diethyl 2-Thienyl Methylmalonate | ||||||
| Hbr-48%(Fg) | ||||||
| L-Proline Benzyl Ester Hydrochloride | ||||||
| Para Nitro Benzyl Bromide | ||||||
| Pyclen Trihydrobromide | ||||||
| Pyrazine Compound | ||||||
| Scopine Di (2-Thienyl) Glycolate | ||||||
| VAM(2) | ||||||
Disclaimer: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement. The liability of any sale into such protected markets is at buyer’s risk.
