Panaji: After barely managing to tide over the storm following the backlash to the out-of-State recruitment drives, members of Goa's highly successful pharma sector has yet another predicament to tackle - meeting best practices' standards in manufacturing processes what with the US drug controller flagging issues in Goa based plants of some major players.
USFDA Inspects The Manufacturing Facility Of Pharma Major Cipla Ltd
Recently, the US Food and Drug Administration (USFDA) inspected the manufacturing facility of pharma major Cipla Ltd at the Verna industrial estate and issued the company six "inspection observations" which it documented in 'Form 483'.
The inspections were conducted over eleven days between June 10-21, the company itself announced in a regulatory filing to Indian stock markets' regulator SEBI.
"We hereby notify that the USFDA has conducted an inspection at the company's manufacturing facility in Goa, India from 10th – 21st June 2024. On conclusion of the inspection, the company received six inspectional observations in Form 483," the regulatory filing by Cipla Ltd, said.
Company Assures To Address All The Observations
In a bid to assure its stakeholders and shareholders, the company however said that it will address all these observations within the stipulated timeframe by working closely with the USFDA.
'Form 483' is a standard format through which the head of the USFDA's inspection team communicates and also explains the findings of the inspection to the company on the final day of the exercise. It however does not amount to a final verdict of the USFDA on the plant's 'good manufacturing practices' (GMP) compliance.
As per USFDA norms, companies are usually provided a 15-day period to file their responses in which they have to explain the steps to be taken to resolve the issues mentioned in the observations.
The company, however, did not specify the nature of the six observations made by the USFDA inspection team.
Impact Of The Development Of Company's Shares
The development had an instant impact on the company's shares on the Indian bourses. The Cipla scrip dropped Rs 9.30 to end at Rs 1,535.15 (nearly 0.6 percent) in a single trading session after the company's regulatory filing on BSE.
The US market contributes a significant 28% of Cipla's global consolidated sales and earlier last year, the USFDA had followed up the 'Form 483' observations with a "warning letter" with regard to another facility of the company located in Pithampur, a town in Madhya Pradesh.
