APIs and Intermediates

Hikal has rich experience in developing APIs and intermediates

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.

Human Health APIs

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   99614-02-5
Ondansetron hydrochloride dihydrate 103639-04-9
Anti-histaminic Triprolidine hydrochloride   6138-79-0
Anti-depressant Bupropion hydrochloride   31677-93-7
Venlafaxine hydrochloride 99300-78-4
Anti-psychotic Quetiapine fumarate   111974-72-2
Memantine hydrochloride   41100-52-1
Anti-lipemic Gemfibrozil 25812-30-0
Hemorheological Pentoxifylline 6493-05-6

# JDMF available

Product pipeline

Hikal has a long API product pipeline to accelerate new product development and sustain your competitiveness. We have rich experience in developing innovative routes using breakthrough technologies such as enzymatic and / or flow chemistry. Hikal proposes to file about six to eight drug master files (DMFs) every year and build a robust product pipeline across therapeutic areas.

Category Product USDMF EDMF CEP CAS No.
Anti-diabetic Vildagliptin   274901-16-5
Sitagliptin phosphate monohydrate       654671-77-9
Sitagliptin hydrochloride       1115-70-4
Canagliflozin     842133-18-0
Dapagliflozin       461432-26-8
Empagliflozin       864070-44-0
Ertugliflozin       1210344-57-2
Anti-thrombotic Apixaban       503612-47-3
Dabigatran       211915-06-9
Dabigatran etexilate mesylate   593282-20-3
Rivaroxaban       366789-02-8
Anti-hypertensive Olmesartan medoxomil   144689-63-4
Anti-inflammation Celecoxib   169590-42-5
Tolfenamic Acid       13710-19-5
Analgesic Butorphanol Tartrate   42408-82-2