Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.
| Photo Credit: Reuters

The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality concerns with the drugmaker’s Kothur manufacturing facility near Hyderabad.

The regulator’s action, which follows an inspection and issue of eight observations in October, is unlikely to impact supplies or existing revenues from the facility, Natco said in a filing. However, it added that the move may result in delay or withholding of pending product approvals from the site.

Without detailing the contents of the April 8 warning letter, the company said it would respond within the stipulated timelines and work closely with the FDA to address the concerns in a timely manner so as to ensure sustained compliance. Natco said it also remains committed to being compliant with current good manufacturing practices (CGMP) and ensuring it supplies high-quality products to its customers and patients globally.

In October, the company had said its Kothur manufacturing facility had undergone a routine CGMP inspection from October 9-18 at the end of which the U.S. FDA has issued eight observations. Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.

The plant produces formulations and makes oral and solid dosages, including dry powder, cytotoxic and noncytotoxic orals and cytotoxic injectables, according to the company’s website.

Representational image only.
| Photo Credit: The Hindu

Biocon Limited on October 18 said the U.S. health regulator has classified as ‘official action indicated’ for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection.

The OAI (Official Action Indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Limited said in a regulatory filing.

“Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Limited, has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 GMP inspection at its insulins manufacturing facility at Johor, Malaysia,” a company spokesperson said in the filing.

The USFDA has “determined the inspection classification as ‘OAI’ (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility”, the spokesperson added.

As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

The spokesperson said the company has submitted a comprehensive corrective and Preventive Action (CAPA) plan to the USFDA in response to observations from the July inspection and believe it is on track to complete all actions as committed.

“The company will continue to engage with the agency to understand any outstanding concerns and work closely to address them expeditiously. We do not believe that this will have a material impact on the manufacturing and distribution of the company’s commercial products for the U.S. market,” the spokesperson said.