. Dr. Reddy’s exhibits promising growth prospects as regulatory concerns subside

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Dr. Reddy’s exhibits promising growth prospects as regulatory concerns subside

In the last one-two years Dr. Reddy’s Laboratories Ltd has faced deteriorating earnings profile, however, the scenario now seems to improve due to easing regulatory concerns and expected launch of certain high-value products in the US.

Dr. Reddy’s received US Food and Drug Administration (USFDA) approval for couple of its manufacturing units. Also with a promising product pipeline for the US markets, Dr Reddy’s Laboratories holds favourable position.

Clearance of the company’s formulations plant at Bachupally, Hyderabad, by the USFDA eased fears that the Form 483 issued to the unit in April would be converted into a warning letter . The unit accounts for 50-60% of sales in the US.

On December 11, the company stated that it has received an Establishment Inspection Report (EIR) from the USFDA for its Bachupally unit, indicating closure of audit in April when the regulator had issued a Form 483 with 11 observations relating to violation of good manufacturing practices (GMP).

Form 483 is issued by FDA if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related Acts.

In June, the US regulator had cleared Dr. Reddy’s active pharmaceutical ingredients (API) unit at Miryalaguda in Telangana, which was one of the three plants that received a warning letter in November 2015 for violation of GMP norms.

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