Generic Name | CAS | DMF/Project status |
---|---|---|
Acitretin | 55079-83-9 | TP, DMF, CEP,WC,GMP |
Acrivastine; Pseudoephedrine Hydrochloride | 87848-99-5 | TP, DMF,WC,GMP |
Adapalene | 106685-40-9 | Pilot scale |
Alitretinoin | 5300-03-8 | TP, DMF, WC |
Alogliptin Benzoate | 850649-62-6 | DMF 030913 (CHINA) Y20180001211 |
Anastrozole | 120511-73-1 | TP, DMF, GMP |
Apixaban | 503612-47-3 | DMF 030874 (CHINA) Y20180001160 EU.S: DE/H/6542/001-002/DC |
Apremilast | 608141-41-9 | DMF 034088 |
Aripiprazole | 129722-12-9 | DMF 030954 (CEP) RO-CEP 2016-208-Rev 01 (CHINA) Y20190000017 |
Azacitidine | 320-67-2 | VB July 2021 US DMF Feb 2022 Batch size: 5Kg |
Azithromycin | 121470-24-4 | (CEP) RO-CEP 2014-185-Rev 04 DMF 028453 (Approved). (CHINA) Y20190000922. |
Bendamustine Hydrochloride | 3543-75-7 | TP, DMF, WC |
Benzoyl Peroxide | 2685-64-5 | WC |
Bepotastine Besilate | 190786-44-8 | TP, DMF |
Betamethasone Sodium Phosphate | 151-73-5 | TP, DMF, GMP |
Bexarotene | 153559-49-0 | TP, DMF, WC |
Bilastine | 202189-78-4 | TP |
Brivaracetam | 357336-20-0 | DMF 034398 |
Cabazitaxel | 183133-96-2 | VB Oct to Dec 2021 US DMF July 2022 Batch size: 5Kg |
Calcipotriol Anhydrous / Monohydrate | 112965-21-6/ 147657-22-5 | TP, DMF, CEP, WC, GMP |
Calcium Levofolinate | 80433-71-2 | TP, DMF, GMP |
Cholecalciferol 40,000,000 IU/g | 67-97-0 | USDMF Feb 2020 |
Cholecalciferol Concentrate (Powder Form) 100,000 IU/g | 67-97-0 | US DMF |
Clobetasone Butyrate | 25122-57-0 | GMP |
Dapsone | 80-08-0 | WC, GMP |
Desonide | 638-94-8 | GMP |
Docetaxel | 114977-28-5 | VB July to Aug 2021 US DMF Mar 2022 CEP Apr 2022 Batch size: 15Kg |
Droxidopa | 23651-95-8 | Pilot scale |
Efinaconazole | 164650-44-6 | Pilot scale |
Escitalopram Oxalate | 128173-53-5 | (CHINA) Y20170000762 EU-3.2.S: DE/H/6009/-001/004/DC |
Esomeprazole Magnesium | 217087-10-0 | Pilot scale |
Febuxostat | 144060-53-7 | Pilot scale |
Fingolimod Hydrochloride | 162359-56-0 | DMF 028165 (CANADA) DMF 2016-268 CEP 2019140 (CHINA) Y20190021326 |
Isotretinoin | 4759-48-2 | TP, DMF, CEP, WC, GMP |
Levocetirizine Dihydrochloride | 130018-87-0 | TP, DMF, WC, GMP |
Linagliptin | 668270-12-0 | (CHINA) Y20180000097 DMF 028785 (KOREA) DMF 20160264394 |
Linezolid | 165800-03-3 | TP, DMF, GMP |
Moxifloxacin Hydrochloride | 186826-86-8 | CEP2020-402 |
Naftifine Hydrochloride | 65473-14-5 | TP, DMF, WC, GMP |
Olopatadine Hydrochloride | 140462-76-6 | TP, DMF, WC, GMP |
Paclitaxel | 33069-62-4 | VB Jan to May 2021 US DMF Nov 2021 CEP Nov 2021 Batch size: 15Kg Annual capacity: 1200 Kg |
Palonosetron Hydrochloride | 135729-62-3 | TP, DMF |
Paricalcitol | 131918-61-1 | TP, DMF |
Pitavastatin Calcium | 147489-06-3 | Pilot scale |
Prasugrel Hydrochloride | 389574-19-0 | DMF 026769 (Approved) |
Ritonavir | 155213-67-5 | (CHINA) Y20200000590 |
Rivaroxaban | 366789-02-8 | (CHINA) Y20170001898 DMF 028786 EU-3.2.S: DE/H/6415/001-003/DC |
Roflumilast | 162401-32-3 | TP, DMF, WC |
Rosuvastatin Calcium | 147098-20-2 | (CEP) RO-CEP 2015-356-Rev 02 (US) DMF 029397 . (KOREA) DMF 20180324495 (CANADA) DMF 2018-032 (CHINA) Y20180001564 |
Ruxolitinib Phosphate | 1092939-17-7 | TP, DMF |
Sitagliptin Phosphate | 654671-77-9 | CEP 2016-015-Rev01 DMF 030170 (CHINA) Y20180000430 |
Sofosbuvir | 1190307-88-0 | DMF preparation |
Sofosbuvir; Velpatasvir | 1190307-88-0 | DMF preparation |
Solifenacin Succinate | 242478-38-2 | DMF 035140 CEP 2020-263 |
Sugammadex Sodium | 343306-71-8 | DMF 033790 (CHINA) Y20190000672 |
Tadalafil | 171596-29-5 | DMF 032453 (CEP) RO-CEP 2018-005-Rev00 (CHINA) Y20180000809 |
Tazarotene | 118292-40-3 | TP, DMF, WC, GMP |
Tofacitinib Citrate | 54073729-9 | VALIDATION IN PROGRESS |
Tretinoin | 302-79-4 | TP, DMF, WC, GMP |
Vonoprazan | 1260141-27-2 | Pilot scale |
API Generic Name | Project Status | DMF / submission time |
---|---|---|
Abaloparatide | Under process development | |
Atosiban | Stability study (PVB production finished) | Dec, 2021 |
Bivalirudin | Approved in China | Q3, 2021 |
Buserelin | Completed lab scale research | |
Carbetocin | Approved in China. Passed GMP inspection | Q4, 2021 |
Cetrorelix | Completed Lab scale research | |
Degarelix Acetate | Commercial ready Batch size: 2.4kg/batch | DMF 033550 |
Desmopressin | Approved by China NMPA | Q3, 2021 |
Eptifibatide | Approved by China NMPA | |
Etelcalcetide | Started pilot scale research | Q3, 2022 |
Ganirelix Acetate | Under process development | |
Goserelin Acetate | Start pilot scale research Batch size: 500g/batch | Q4 2022 |
Leuprolide Mesylate | Started pilot scale research Batch size: 500g/batch | Q4 2022 |
Linaclotide | Started pilot scale research | Q3, 2022 |
Octreotide Acetate | Submitted DMF | DMF 035563 |
Plecanatide | Under process development | Q1, 2023 |
Salmon Calcitonin | no CAS nbr, Lab scale | |
Semaglutide | Under PVB production | Dec, 2021 |
Sincalide | Sample , COA | |
Somatostatin | Under PVB production | Q4, 2021 |
Terlipressin Acetate | Approved by China NMPA. Passed GMP inspection | Q4, 2021 |
Triptorelin Pamoate | Complete lab scale research Batch size: 500g/batch |