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 regulatory filing status, do refer
to the table below:
Product
USDMF
DMF
in CTD
COS
Gabapentin
--
Bupropion Hydrochloride
--
Gemfibrozil
Ondansetron Hydrochloride
Ondansetron Base
--
Triprolidine Hydrochloride
--
Acebutolol Hydrochloride
--
Levetiracetam
--
Cinnarizine
--
Flunarizine Dihydrochloride
--
--
Pentoxifylline
* API/Substances covered by patent are not offered to the countries where the patent law is in force
