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Hikal has a 20 years+ track record of developing APIs in a dynamic regulatory landscape. We have regulatory approvals from the US FDA-cGMP, TGA-GMP, KFDA (Korea), PMDA (Japan), AFMPS (Belgium), EDQM, EPA, COFEPRIS (Mexico). We rank in a select list of Indian companies with zero 483 observations after US FDA audits of API and intermediate manufacturing facilities.
Hikal has a significant scale up capacity with backward integration capability. Our robust systems, quality and regulatory focus ensure that you benefit from customized APIs.
| Therapeutic Category | Product Name | USDMF | EDMF | CEP | CAS No. |
| Anti-convulsant   | Gabapentin # | ? | ? | ? | 60142-96-3 |
| Pregabalin | ? | ? | ? |  | 148553-50-8 |
| Anti-emetic | Ondansetron | ? | ? | Â | 99614-02-5 |
| Ondansetron | hydrochloride dihydrate | ? | ? | Â | 103639-04-9 |
| Anti-histaminic | Triprolidine hydrochloride | ? | ? | Â | 6138-79-0 |
| Anti-depressant | Bupropion hydrochloride | ? | ? | Â | 31677-93-7 |
| Venlafaxine | hydrochloride | ? | ? | ? | 99300-78-4 |
| Anti-psychotic | Quetiapine fumarate | ? | ? | Â | 111974-72-2 |
| Memantine | hydrochloride | ? | ? | Â | 41100-52-1 |
| Anti-lipemic | Gemfibrozil  | ? | ? | ? | 25812-30-0 |
| Hemorheological  | Pentoxifylline  | ? | ? | ? | 6493-05-6 |
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APIs and Intermediates
Hikal manufactures APIs and intermediates for global innovator companies. Our capabilities in chemistry have shaped a product portfolio through non-infringing processes. Our state-of-theart cGMP manufacturing facilities coupled with robust supply chain management enable us to serve global innovator and life sciences companies.
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No. 3- A, International Biotech Park, Hinjewadi Phase-Ii, Hinjewadi,Pune
Rating: 4
Phone: 8886142950
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