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| .: ACTIVITIES |
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For Business Inquiries please click here |
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| Activities
pertaining to APIs/ Bulk Drugs Development |
We develop cost-effective and eco-friendly
processes for drugs and their intermediates.
We have gained significant expertise in
developing processes for macrolides and
ketolides apart from handling various
organic reactions. The non-infringing / 1st
expiry processes developed by R&D lead
Alembic to file DMF’s with US FDA. Process
development of API for generic markets
remains the key focus. Alembic is one of the
two organisations in India which produce
phosgene based chemicals.
Equipped with the state of art world class
analytical instruments like XRD, LC/MS/MS,
Proton and carbon NMR, our Analytical
Development laboratory is the backbone for
development and validation of analytical
methods besides making impurity profiles and
quantification of polymorphs. As many as 100
scientists work on process innovation and
simplification, cycle time reduction and
continuous process improvement.
The Company’s R & D strengths are in
developing intellectual property in the area
of non-infringing processes and resolving
complex chemistry challenges. A strong IPR
cell at Alembic Ltd. facilitates the
scientists in creation and protection of
intellectual property with necessary
documentation.
Our operations are supported by well
documented systems and procedures and are
ISO-9000 certified. A separate department
called DQA (Development QA) is dedicated to
R&D and ADL to guide the scientists for
achieving compliance with respect to QA and
RA requirements.
Our fully equipped Kilo lab, pilot plant and
manufacturing plants and their sophisticated
infrastructure give us a competitive edge in
R&D operations.
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FERMENTATION RESEARCH
Alembic has pioneered the
fermentation of antibiotics. In
1961, we introduced Penicillin. That
was followed by the launch of
Erythromycin fermentation in India,
in 1971, and then recently we
introduced Cephalosporin-C.
A major part of our R&D effort is
devoted to microbiology. Activities
at the Micro Research and
Development Lab include |
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Maintenance and preservation of
industrial strains |
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Productivity improvement of strains
by mutation |
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Random as well as rational selection
method |
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Primary, secondary and final
screening of the improved isolates
at the shake flask level and
evaluation of cheap raw material at
the shake flask level towards the
development of cost effective
process |
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Activities at the Pilot Plant
include |
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Evaluation of improved isolates at
different scale (from 150L to 2000L
fermenters) |
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Medium optimization studies |
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Fermenter design studies and
feasibility studies of gradual
replacement of manual/ mechanical
operations by Distributed Control
System |
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| It is our constant endeavor to optimize
and improve imported technology to suit
local conditions. |
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