Aurobindo Pharmaceuticals (APL) has a big relief in form of Establishment
Inspection report (EIR) for Unit-4 facility in which the USFDA has closed
issued Form 483. The Form 483 is issued to a firms management at
the conclusion of an inspection when an investigator(s) has observed
any conditions that may constitute violations of the Food Drug and
Cosmetic (FD&C) Act and related Acts. USFDA had inspected Unit 4
facility in December and issued Form 483, with two observations. Unit
4 EIR is very important for the company, as it has filed totally 101
products from this facility of which 58 are approved by the USFDA (as
on 31 Dec’2018). As on December’2018, the company had filed 519 US
ANDA’s with 369 already approved.
Since we have already built in the numbers the potential from the
Injectable business we are not changing our estimates and maintain
our Buy with a revised target of `890.
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