(By Balaseshan) India-based Dr. Reddy's Laboratories Ltd. (NYSE:RDY) said the import alert at its chemical manufacturing facility at Cuernavaca, Mexico has been lifted by the U.S. regulatory authorities.
The import alert at Quimicas Falcon de Mexico SA de C.V. (Dr. Reddy's chemical manufacturing facility at Cuernavaca, Mexico), a subsidiary of Dr. Reddy's Laboratories, has been lifted.
The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients. Dr. Reddy's received a clearance from the United States Food and Drug Administration (USFDA) on July 26.
In November 2010, Dr. Reddy's Mexico facility was inspected by USFDA. Based on observations by the USFDA, a Warning Letter was shared on June 14, 2011 with the company.
Dr. Reddy's worked with USFDA to resolve the observations in the Warning Letter. An inspection report after the last inspection from March 26 to 30 indicated that they are satisfied with all the outstanding action points that Dr. Reddy's has submitted.
With the satisfactory closure of observations in the warning Letter and the lifting of the import alert, Dr. Reddy's can now start importing products to the U.S. from this facility.
Dr. Reddy's Laboratories is an integrated global pharmaceutical company. The company operates in three segments: Pharmaceutical Services and Active Ingredients, Global Generics, and Proprietary Products.
RDY is trading down 1.29% at $29.15 on Friday. The stock has been trading between $27.28 and $36.33 for the past 52 weeks.