“We have now been informed by USFDA that based on its evaluation, we have addressed the violations
Dr. Reddy’s Laboratories on Friday said a warning letter the U.S. Food and Drug Administration (USFDA) issued almost five years ago to three of its manufacturing facilities had been closed.
“We have now been informed by USFDA that based on its evaluation, we have addressed the violations and deviations contained in the said warning letter… With this, the said warning letter has been closed,” said Dr.Reddy’s. informed the stock exchange.
Dr Reddys Laboratories launches Methylphenidate Hydrochloride Extended-Release TabletsThe November 20 15 letter related to API manufacturing facilities in Srikakulum (Andhra Pradesh) and Miryalguda (Telangana) and the Oncology formulation manu factu ring facility, Visakhapatnam.Dr Reddys Laboratories announced the launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a therapeutic equivalent generic version of Concerta (met hylphe nidate Hydrochloride) Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg, approved by the U. S. Food and Drug Administration (USFDA).
The Concerta brand and generic market had U. S. sales of approximately $1.159 billion MAT for the most recent twelve months ending in June 2020 according to IQVIA Health. Dr. Reddy’s Methylphenidate Hydrochloride Ext ended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.Dr. Reddy
