Dr Reddy's gets seven observations from USFDA for Andhra plant
has received a
Form 483
with seven observations from the US health regulator for its Srikakulam-based plant in
Andhra Pradesh
, according to a regulatory filing.
The US Food and Drug Administration (
USFDA
) conducted the GMP and a Pre-Approval Inspection (PAI) at the formulations manufacturing facility from July 10 to 18, 2025, the Hyderabad-based drug major said in the filing.
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"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," it added.
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As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.
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Time of India
39 minutes ago
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What are the themes and is the investment philosophy at present? Nikhil Ranka : Two sectors where we are relatively bullishly positioned are cement and telecom. Both the sectors are in an oligopoly structure. In telecom for example, Reliance and Bharti together account for close to 80% of the market share and global uncertainty has very little impact on the earnings for these sectors. We had a tariff hike nine months back that has more or less got absorbed and in the next three to six months, we are looking forward to one more tariff hike and the incremental flow through of EBITDA for telecom companies is almost 70% because the costs are more or less fixed in nature. For telecom, infrastructure cost is the major cost which does not change so much and therefore, we believe that it is one of the sectors where earnings visibility is high and multiples should sustain. Secondly, in cement, the replacement cost is close to $120. 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Time of India
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