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Company Watch
FDC gets US FDA nod for ciprofloxacin solution
Our News Bureau - Mumbai
 FDC
has recently got US FDA nod for its abbreviated new drug application (ANDA),
ciprofloxacin ophthalmic solution. It is a broad spectrum antibiotic which is
used for occular surface infections. The company has also received approval
for timolol maleate ophthalmic solution. And another of its ANDAs, ofloxacin
ophthalmic solution is in the final stages for approval. Besides these three
ANDAs, FDC is at an advanced stage of filing five more ANDAs. FDC has also to
its credit twelve Drug Master Files (DMFs) and ten marketing authorisations
in the UK with a strong marketing presence.
According to a company note, FDC's Waluj facility (the ophthalmic, oral liquids,
external powders and oral powder sections) was recently approved by the US FDA
without a single 483 (no deviations). With a state-of-the-art R&D facility
for biotechnology and a dedicated and qualified research team, FDC is poised
to enter the biotech segment soon. Besides this, FDC is in the final stages
of data submission awaiting clearance for conducting pre-clinical and clinical
trials for a biotech product with a significant sales potential.
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