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.

Commercial products

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 #

Pregabalin




60142-96-3
148553-50-8
Anti-emetic Ondansetron

Ondansetron Hydrochloride Dihydrate




99614-02-5
103639-04-9
Anti-histaminic Triprolidine Hydrochloride 6138-79-0
Anti-depressant Bupropion Hydrochloride

Venlafaxine Hydrochloride




31677-93-7
99300-78-4
Anti-psychotic Quetiapine Fumarate

Memantine Hydrochloride




111974-72-2
41100-52-1
Anti-lipemic Gemfibrozil 25812-30-0
Hemorheologic 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.

Therapeutic Category Product Name USDMF EDMF CEP CAS No.
Anti-diabetic Vildagliptin

Sitagliptin Phosphate Monohydrate


Sitagliptin Hydrochloride


Canagliflozin


Dapagliflozin


Empagliflozin


Ertugliflozin



















274901-16-5

654671-77-9
1115-70-4
842133-18-0

461432-26-8

864070-44-0

1210344-57-2
Anti-thrombotic Apixaban

Dabigatran


Dabigatran Etexilate Mesylate


Rivaroxaban











503612-47-3

211915-06-9
593282-20-3

366789-02-8
Anti-viral Valacyclovir Hydrochloride 124832-27-5
Anti-hypertensive Olmesartan Medoxomil 144689-63-4
Anti-inflammation Celecoxib

Tolfenamic Acid




169590-42-5
13710-19-5
Analgesic Butorphanol Tartrate 42408-82-2