The US Food and Drug Administration has issued a warning letter to Cipla after receiving thousands of complaints of defective products in the last couple of years.
In the warning letter issued on Friday 17 November, the FDA highlighted several violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals, after an inspection of its Pithampur site in Indore, Madhya Pradesh, earlier this year.
The company has received approximately 3,000 complaints about its albuterol sulfate inhalation aerosol product since the start of commercial manufacturing in April 2020, according to the FDA. After a risk assessment in 2021, Cipla concluded that there was no risk to product quality and patient safety.
An additional 2,000 complaints were received between January and August this year citing issues such as “no spray”, “empty/less weight” and leaky containers. The inspection also uncovered that the firm did not submit a new drug application (NDA) or abbreviated new drug application (ANDA) field alert report (FAR) to the agency.
Cipla identified that there was a problem with the container-closure system, resulting in particles blocking the delivery of the drug. The FDA stated in the warning letter that the company did not make any recalls after identifying this issue, and affected batches remained on the market until their expiration dates.
Cipla recalled six batches of albuterol sulfate inhalation aerosol on 27 June 2023, due to a defective valve lot that had a partially missing bottom seat (gasket) however according to the FDA, the company did not broaden its appraisals to the other batches that could have also been damaged.
This warning letter has delayed launch timelines for its generic Advair in the US. The product is the generic version of GSK’s Advair Diskus. Advair is a fixed-dose combination medication containing fluticasone propionate and salmeterol. It is used in the management of asthma and chronic obstructive pulmonary disease. GSK’s Advair generated $1.2bn in sales last year, according to its 2022 annual report. The report noted that sales of Advair had decreased 15% at AER, reflecting the impact of generic competition.
While historically known for its generics manufactured in India, especially during the HIV crisis, in recent years, Cipla has expanded its operations. In September, the company acquired South African company Actor Pharma through its subsidiary Cipla Medpro South Africa, as part of its growth plans in the region.
In 2017, the company invested $88m in the construction of a manufacturing plant in South Africa to make biosimilars. Earlier this year, Cipla also signed a licence deal with Novartis to manufacture and market the latter’s diabetes drug Galvus, along with its combinations.
