The Indian multinational biotechnology and pharmaceutical company-Cipla has dropped to 5% in Friday’s session. The dive is attributed to extensive changes by Capital market company-Equirius, which said the unit will have to meet the changes as per the USFDA guidelines.
News sources of Equirius allege the unit received Form 483 with 12 observations and is compiled within 38 pages. Furthermore, the Mumbai based capital company said the observations were based on procedure and SOP lapses.
In addition, sources reveal the unit is responsible for about one-third of the US businesses. The facility will therefore need extensive changes in SOPs processes and procedures.
Founded in 2007, Equirius said, given the complexity of the issue, it could take longer than expected to resolve. The company also claims it sees the possibility of a likelihood of OAI (Official Action indicated) classification and hence the likelihood of even a warning letter.
Furthermore, reports allege, a cGMP inspection was undertaken by United States Food and Drug Administration (USFDA) at the manufacturing facility in Goa this year during September 16-17.
With regards to the situation, Cipla claimed on September 28: “The inspection ended with 12 observations, none of which are related to data integrity. The Company will respond to the agency within the stipulated timeline.”
At 10 a.m., the stock traded down 5 percent at Rs 405 level on BSE. On Monday, Cipla has closed 3.28 percent, thus facing a 52-week low growth process. Its Goa facility has undergone 12 observations from the US drug regulator after inspections. In a statement, Cipla however clarified, the observations were related to data integrity.
In the wake of the situation, growth sales of Indian pharma companies in the US have lately faced the pressure with regards to pricing issues.
Tags : Cipla, Biotechnology and Pharmaceutical company, India, Equirius, United States Food and Drug Administration, USFDA,