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.

Drug-maker Glenmark Pharmaceuticals’ Apremilast Tablets, 10 mg, 20 mg and 30 mg, a generic version of Amgen’s Otezla Tablets, 10 mg, 20 mg and 30 mg, has received final approval from the United States Food and Drug Administration (U.S. FDA).

Otezla Tablets brand and therapeutic equivalents achieved annual sales of around $3.7 billion, Glenmark said citing IQVIA sales data for the 12-month period ending August 2023.

A phosphodiesterase 4 (PDE4) inhibitor, Apremilast is indicated for treating psoriatic arthritis plaque psoriasis and Behcet disease associated with oral ulcers.

Glenmark said its portfolio consists of 188 products authorised for distribution in the U.S. market while 50 abbreviated new drug applications (ANDAs) are pending approval with the U.S. FDA. It also continued to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.