Regulatory and Quality Systems
Hikal has developed several APIs for multinational companies. Hikal adopts advanced quality systems and undertakes periodic audits and procedural documentation. Our Regulatory Affairs department supports preparation and filing of DMF's in CTD format as per international guidelines for US, EU and other countries and follow up on query responses and COS to ensure approvals within minimum time frame.

Major pharmaceutical companies have audited our facilities and rated them on par with the best in the world. Our state-of-the-art, multipurpose production plants are ISO 9001-2000 compliant and follow cGMP standards. Our plant at Bangalore is approved by USFDA, TGA and WHO GMP.
For our list of commercialized APIs and it's regulatory filing status, do refer to the table below:

APIs CAS # USDMF DMF in CTD COS

Gabapentin 60142-96-3 -- Bupropion Hydrochloride 31677-93-7 -- Gemfibrozil 25812-30-0 Ondansetron Hydrochloride 99614-01-4 Ondansetron Base 99614 -02-5 -- Memantine Hydrochloride 41100-52-1 -- -- Triprolidine Hydrochloride 6138-79-0 -- Venlafaxine Hydrochloride 99300-78-4 -- Acebutolol Hydrochloride 34381-68-5 -- Levetiracetam 102767-28-2 -- Cinnarizine 298-57-7 -- Flunarizine Dihydrochloride 30484-77-6 -- -- Topiramate 97240-79-4 -- -- Pentoxifylline 6493-05-6

* API/Substances covered by patent are not offered to the countries where the patent law is in force