Cipla Stock Falls After 8 Observations from GMP Inspection
On 17 February 2023, the US Food and Drug Administration (FDA) issued big pharma company Cipla a Form 483 which included eight observations of objectionable manufacturing conditions after a GMP inspection to their plant in Pithampur, India.
The multinational company’s stock consequently dipped by 7% to 955.25 INR on Monday, its lowest price in seven months.
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The FDA conducted a good manufacturing practice (GMP) inspection from 6 – 17 February 2023. On 18 February, Cipla submitted a regulatory filing that stated the following:
“On conclusion of the inspection, the Company has received 8 inspectional observations in Form 483. The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time.”
GMP is the standard by which regulators expect pharma manufacturing companies to adhere to. The benchmark covers all aspects of the production process from record keeping, to sanitation, to staff qualification.
The facility in Madhya Pradesh state is one of the company’s key industrial sites. Among others, it is responsible for the manufacture of Cipla’s generic inhaled drugs Proventil, Brovana, and Pulmicort.
In 2020, Cipla applied for an abbreviated new drug application (ANDA) to manufacture a generic version of GSK’s Advair—an inhaled therapy for chronic pulmonary diseases—from the Pithampur facility.
It is yet unclear as to the nature of the company’s deviations from GMP. Minor problems can be resolved quickly, with the impact on the company being a loss of sales and a decrease in share price. More severe infringements may take longer to settle, the FDA having the final say on any further action that must be taken.
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