Actylis has exclusively developed several excipients with Type IV DMF filing with US FDA & China CDE with National Medical Products Administration (NMPA) for use in various drug formulations that are intended for NDA / ANDA filing. Complete regulatory documentation support, open part of DMF & Letter of Access (LOA) can be issued to customers.
| CAS No. | Product Name | US DMF No. | China DMF No. |
|---|---|---|---|
| 64-19-7 | Acetic acid glacial | - | CDE # F20210000515 |
| 67-64-1 | Acetone | - | CDE # F20200000009 |
| 75-05-8 | Acetonitrile | DMF # 26612 | CDE # F20200000271 |
| 631-61-8 | Ammonium Acetate | DMF # 037417 | CDE # F20230000198 |
| 100-51-6 | Benzyl Alcohol | - | CDE # F20210000324 |
| 98-11-3 | Benzene sulphonic acid | DMF # 30281 | CDE # F20180001463 |
| 120-51-4 | Benzyl Benzoate | - | CDE # F20190000461 |
| 25013-16-5 | Butylated hydroxyanisole | - | CDE # F20200000188 |
| 128-37-0 | Butylated hydroxytoluene | - | CDE # F20200000189 |
| 5793-89-5 | Calcium Saccharate | - | CDE # F20200000092 |
| 60-27-5 | Creatinine | - | CDE # F20200000002 |
| 110-82-7 | Cyclohexane | DMF # 26698 | - |
| 67-43-6 | Diethylene triamine pentaacetic acid (Pentetic acid) | - | CDE # F20210000391 |
| 67-68-5 | Dimethyl Sulfoxide | - | CDE # F20220000370 |
| 6381-92-6 | Disodium Edetate | - | CDE # F20220000055 |
| 6106-21-4 | Di - Sodium succinate hexahydrate | DMF # 31178 | CDE # F20200000141 |
| 110-17-8 | Fumaric Acid | - | CDE # F20200000212 |
| 56-81-5 | Glycerin | - | CDE # F20200000003 |
| 56-81-5 | Glycerine Synthetic | - | CDE # F20210000594 |
| 56-81-5 | Glycerol 85% | - | CDE # F20210000504 |
| 107-41-5 | Hexylene glycol | - | CDE # F20200000515 |
| 67-63-0 | Isopropyl Alcohol (IPA) | - | CDE # F20200000010 |
| 6283-92-7 | Lauryl lactate | DMF # 31766 | - |
| 123-76-2 | Levulinic Acid | DMF # 31434 | CDE # F20190000626 |
| 6284-40-8 | Meglumine | - | CDE # F20210000204 |
| 108-39-4 | meta-Cresol | - | CDE # F20190000234 |
| 75-75-2 | Methane sulphonic acid | DMF # 32834 | CDE # F20190000136 |
| 75-09-2 | Methylene chloride (Dichloromethane) | CDE # F20200000329 | |
| 50610-34-9 | Monosodium glycine carbonate | DMF # 26697 | - |
| 96-27-5 | Monothioglycerol | - | CDE # F20180001740 |
| 127-19-5 | N,N-Dimethyl acetamide | DMF # 26702 | CDE # F20190000639 |
| 142-82-5 | N-Heptane | DMF # 30536 | CDE # F20220000475 |
| 60-12-8 | Phenylethyl Alcohol | - | CDE # F20220000576 |
| 57-55-6 | Propylene glycol | - | CDE # F20200000457 |
| 144-55-8 | Sodium Bicarbonate | - | CDE # F20230000003 |
| 7631-90-5 | Sodium bisulfite | - | CDE # F20210000237 |
| 497-19-8 | Sodium Carbonate | - | CDE # F20230000002 |
| 1002-62-6 | Sodium Caprate | DMF # 037296 | CDE # F20220000180 |
| 7647-14-5 | Sodium Chloride | - | CDE # F20210000255 |
| 7681-57-4 | Sodium metabisulphite | - | CDE # F20200000447 |
| 6106-24-7 | Sodium tartrate | - | CDE # F20220000324 |
| 110-15-6 | Succinic acid | - | CDE # F20200000397 |
| 87-69-4 | Tartaric Acid | - | CDE # F20200000007 |
| 75-65-0 | tert - Butanol | DMF # 24710 | CDE # F20180001596 |
| 78-10-4 | Tetraethyl Orthosilicate | DMF # 34762 | - |
| 102-76-1 | Triacetin | - | CDE # F20210000329 |
| 77-93-0 | Triethyl citrate | - | CDE # F20200000446 |
| 102-71-6 | Trolamine | - | CDE # F20210000049 |
