Dr Reddy’s Laboratories dipped 7% to Rs 2,066 on the National Stock Exchange (NSE) in intra-day trade after the company said its formulations manufacturing facility in Duvvada, Vishakhapatnam, got zero critical and six major observations from the Regulatory Authority of Germany.
“The products manufactured at the facility are not currently exported to EU. The company will be submitting a corrective and preventive action plan (CAPA) to the authorities,” Dr Reddy’s Laboratories said in a statement.
The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit on September 7, 2017.
The auditor has cautioned that the facility will receive EU-GMP (Good Manufacturing Practices) certification from the regulator upto November 2018 when the regulator approves the CAPA.
The facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by the November 2018 for continuation of the facility’s EU-GMP certification.
At 11:14 AM, the stock recovered from its intra-day loss and trading 3% lower at Rs 2,165 on NSE, against 0.15% rise in Nifty 50 index. A combined 1.16 million shares changed hands on the counter on BSE and NSE.
“The products manufactured at the facility are not currently exported to EU. The company will be submitting a corrective and preventive action plan (CAPA) to the authorities,” Dr Reddy’s Laboratories said in a statement.
The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit on September 7, 2017.
The auditor has cautioned that the facility will receive EU-GMP (Good Manufacturing Practices) certification from the regulator upto November 2018 when the regulator approves the CAPA.
The facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by the November 2018 for continuation of the facility’s EU-GMP certification.
At 11:14 AM, the stock recovered from its intra-day loss and trading 3% lower at Rs 2,165 on NSE, against 0.15% rise in Nifty 50 index. A combined 1.16 million shares changed hands on the counter on BSE and NSE.