Warning letters for pharma cos galore: Now Cadila Healthcare faces USFDA heat, stock tanks 16%

It’s raining warning letters for home-grown listed pharma companies. After Sun Pharmaceuticals, India’s largest pharmaceutical company, was handed a warning letter earlier this month for irregularities at one of its unit, the US drug regulator, the USFDA, stepped up its action and issued a similar warning letter to Cadila Healthcare for quality and non-compliance matters.  The Ahmedabad-headquartered company received a warning letter for its Moraiya formulation facility and Ahmedabad API facility. “We take quality and compliance matters very seriously and stand by our commitment to fully comply with cGMP quality standards across all our facilities. The Company is working hard to ensure that the commitments made to the US FDA are fully completed. The Company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facilities,” Cadila Healthcare said in a statement issued to BSE. “We further state that our products in the market are safe and effective and we are committed to supply the quality products to our customers across the globe,” the release said further. The company also said it will respond to US FDA to address the observations within the statutory time permitted in the letter. Despite the company’s statement to calm investors’ sentiment, the stock already faced severe battering on the bourses. A short while ago, Cadila stock in a severe bear hammering tanked nearly 17 percent to a low of Rs 320.45. At 11 am, the stock was traded at Rs 326.25, down 15.3 percent over previous close. Nearly 18 lakh shares changed hands on BSE as against two-week average volume of 1.6 lakh shares. Today’s fresh warning letter comes weeks after Sun Pharma had received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat. The cause of concern for Sun Pharma is that its Halol plant makes up about 15 percent of Sun Pharma’s sales in its largest market, the United States. The plant assumes significance for the company as it can manufacture injectable products, which are difficult to make and hence a niche and lucrative market for drugmakers. The company is already grappling with US import bans on five of its other manufacturing facilities in India. Since last September, Sun Pharma has not received any US approvals to launch new drugs made at Halol. Another pharma major, Dr Reddy’s Laboratories was also handed a warning letter last month relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana. The US agency had asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data and include a detailed action plan to fully investigate the scale and root causes of “deficient documentation and data management practices”. In October, The U.S. Food and Drug Administration had warned Novartis AG after the Swiss firm was found in violation of manufacturing practices last year at two of its India drug-making plants. The warning, issued to Novartis’s generic drugs unit Sandoz came after FDA officials inspected its Turbhe and Kalwa sites in western India in August 2014. With inputs from Agencies