Active
Pharmaceutical Ingredients
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Kopran manufactures a range of APIs
including Sterile Cephalosporins in its state of art facility at Mahad,
Maharashtra. Manufacturing of any Sterile API needs excellent facility and
quality systems. Kopran has always been a major player in the
manufacturing of Sterile Cephalosporins. Apart from Sterile API, we can
provide a range of Speciality products which include Macrolides and
Cardiovascular range among others. For many of our APIs, we hold
Certificate of Suitability.
European
Directorate for Quality of Medicines (EDQM)
Atenolol (COS)
Cephalosporin (Non Sterile)
Cephalosporin (Sterile) - under
approval
Manufacturing Facilities
The division has a well defined quality management system and
Good Manufacturing
Practice (‘GMP’).
Leveraging on the in house
expertise and in house research, this division
has concentrated on high value drugs which require technological expertise.
Built in 1996, spread over 36,000 sq. mtrs. within Maharashtra
Industrial
Development Corporation (MIDC) Mahad, built as per FDA norms and complying
with
WHO norms, the plant is a versatile plant capable of manufacturing
over 20 products.
The manufacturing facility is well supported by a state of the art
contained Pilot plant
for the purpose of scaling up of the process.
The
industrial effluent treatment plant has a installed capacity of treating 250 m3/day
with a total connected load of 150 H.P treating nearly 150 m3 of water daily.
A whole range of Pharmaceutical raw
materials primarily high value in various
therapeutic groups :
Anti-Infectives (both Sterile and Oral)
Cardiology
Gastroenterology
Analgesics
Anti-AIDS
Process Capabilities
Production of Chemical
Intermediates and Active Pharmaceutical Ingredients by:
Manufacturing
Capabilities
Our production plant contains-
Reaction vessels with volumes from 50 ltrs. to 9000 ltrs. working under vacuum
and
pressure upto 30 kgs. Total working capacity of all the vessels
together is 127000 ltrs.
Facility to go upto the temp. 150oC and as low as (-)95oC.
Reaction vessels of various material of construction viz. stainless steel,
carbon steel,
glass lined, tiled lined, carbon lined etc.
Pelletisation machines.
Rectification and distillation columns.
Centrifuges.
Vacuum and pressure filters.
Various types of dryers.
Various types of micronisers.
Dedicated facility for Sterile product manufacturing.
Processing plant for water, waste and waste air.
These plants facilitate the
production of various organic intermediates and bulk pharmaceutical chemicals
(APIs). The high quality standard of our products is guaranteed by production
according to the cGMP regulation. Facilities meet current requirement of various
regulatory authorities with several active Drug Master Files.
The extensive experience in
Organic Chemistry coupled with GMP capabilities allows Kopran
to provide its customers with a wide range of services in Organic Synthesis for
custom manufacturing and the production of active pharmaceutical ingredients.
The team of dedicated
Scientists with a state of the art Research Centre supported by pilot plant can
meet the challenges of increasing customer demands as well as responding to our
responsibilities for the environment.
The independence of the
Research team means that customers are assured that Contract Research is carried
out confidentially and exclusively.
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For more
detail information, Contact us.
