Dr Reddy’s Laboratories Ltd, a leading pharmaceutical company, has announced the launch of Doxycycline Capsules, 40 mg, in the US market. This new offering serves as a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg, approved by the US Food and Drug Administration (USFDA).
The 40 mg doxycycline capsules, approved by the US FDA, are supplied in bottle counts of 30. Each capsule contains 26 mg immediate-release pellets and 14 mg delayed-release pellets, totaling 40 mg of anhydrous doxycycline, USP.
This launch expands Dr Reddy’s portfolio of pharmaceutical products aimed at addressing various medical needs. However, it comes after a recent voluntary recall of six lots of medication from the US market by Dr Reddy’s Laboratories. The recalled medication, indicated to reduce blood phenylalanine (Phe) levels, was found to be subpotent.
The recall was initiated due to powder discoloration in some packets, leading to decreased potency. Dr Reddy’s Laboratories identified the issue during an accelerated stability test, along with customer complaints. The reduced efficacy of the product may result in elevated Phe levels in patients, posing potential risks, especially for infants and children.
Chronically elevated Phe levels in this demographic can lead to permanent neurocognitive deficits, including intellectual disability, developmental delay, and seizures.
Despite the recent recall, shares of Dr Reddy’s Laboratories Ltd ended positively on the Bombay Stock Exchange (BSE), closing at ₹6,332.85, up by ₹44.55, or 0.71%.
The launch of the 40 mg doxycycline capsules underscores Dr Reddy’s commitment to providing affordable and effective treatment options to patients in the US market, further solidifying its position as a key player in the global pharmaceutical industry.
