)
Ipca Laboratories has dipped 6% to Rs 788 on National Stock Exchange (NSE) after drug maker said it has received certain inspection observations from the US Food and Drug Administration (FDA) over manufacturing at its Ratlam plant in Madhya Pradesh.
The stock opened at Rs 843 and touched a low of Rs 767 on NSE. A combined 258,000 shares changed hands on the counter in first half-an-hour of trading on NSE and BSE.
The company said it has stopped shipments from the company's Active Pharmaceutical Ingredients (APls) manufacturing facility situated at Ratlam, Madhya Pradesh for the US markets.
During the recent US FDA inspection at the company's APIs manufacturing facility situated at Madhya Pradesh the company has received certain inspection observations in Form483 from the US FDA, IPCA Laboratories said in a statement.
Consequent to this, the Company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed, it added.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the company's formulations export business to the US market since the Company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from the Company's Ratlam manufacturing facility for manufacturing formulations for the US market.
The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture.
The stock opened at Rs 843 and touched a low of Rs 767 on NSE. A combined 258,000 shares changed hands on the counter in first half-an-hour of trading on NSE and BSE.
The company said it has stopped shipments from the company's Active Pharmaceutical Ingredients (APls) manufacturing facility situated at Ratlam, Madhya Pradesh for the US markets.
During the recent US FDA inspection at the company's APIs manufacturing facility situated at Madhya Pradesh the company has received certain inspection observations in Form483 from the US FDA, IPCA Laboratories said in a statement.
Consequent to this, the Company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed, it added.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the company's formulations export business to the US market since the Company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from the Company's Ratlam manufacturing facility for manufacturing formulations for the US market.
The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture.
