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From India to NJ, the core of the FDA’s instructions to Lupin subsidiary Novel Laboratories were the same: establish proper cleaning and process validation guidelines at your manufacturing sites. And after failing to do so for the third time in four years, the company has received a warning letter. Drug residue on tablet presses and a failure to validate the manufacturing process after equipment changes were just two of the issues raised by the FDA after an inspection of a Novel Laboratories plant that led to the June 11 letter. The FDA said that Novel Laboratories’ Somerset, NJ plant had violations of current good manufacturing practice regulations such as an inadequate cleaning procedure and quality control procedures. It’s the first violation at this site, but the third in four years for sites within the company’s network. Novel Labs is a subsidiary of Lupin. Two of the company’s sites in India, one in Goa and another in Mandideep, were issued warning letters in 2017 and 2019, respectively, for similar cGMP violations. Those two facilities made products that, at the time, made up more than 40% of Lupin’s sales. The company did not respond to a request for comment by the time of publication Thursday. “This is a big negative for the company … The warning letter will not only delay new approvals, thus impacting US revenues, but also increase remediation cost that will put pressure on margins,” brokerage firm Edelweiss Securities said in regards to the previous two letters. “Repeated violations at multiple sites demonstrate that your company’s corporate oversight and control over the manufacture of drugs is inadequate,” the letter stated. “You should further comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the drug products manufactured, conform to FDA requirements at all your sites.” The quality unit failed to establish and follow written procedures to ensure the drug was up to standards. The FDA said the cleaning protocol didn’t have adequate oversight, and the company failed to complete the required annual product review. While the company previously made commitments to strengthen operations and acknowledged a need for more quality unit oversight, it failed to provide a comprehensive assessment of all written procedures, the letter said. Novel Labs is required to follow up with responses to the FDA for the following:

Sotera Employees Misappropriated Masimo Trade Secr The FDA issued warning letters to Lupin for two of its manufacturing facilities in Goa and Pithampur, Indore. The U.S. Food and Drug Administration (FDA) issued warning letters to India-based Lupin Ltd., for two of its manufacturing facilities in Goa and Pithampur, Indore. On April 7, the FDA cited three Form-483 observations for the plant in Goa and on May 18, cited six for the Indore location. The FDA issues Form 483 when it concludes an inspection when an investigator observed conditions that he or she feels may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Form 483 is not intended to be all-inclusive and doesn’t include questionable or unknown things observed at the time of the inspection. In a filing to the Bombay Stock Exchange (BSE), Lupin stated, “The company has received a warning letter issued by the United States Food and Drug Administration (USFDA) on November 6, 2017 for our formulation manufacturing facilities at Goa and Indore (Pithampur Unit II).” The Economic Times of India went on to say , “The company is deeply disappointed to have received this outcome, it said, adding that while there will be no disruption of product supplies from either of these locations, there is likely to be a delay of new product approvals.” Lupin didn’t indicate the specifics of the Form-483s. It did say, “We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest.” Company stock dropped as much as 17.9 percent at the news. The two factories contribute more than 50 percent of the company’s U.S. sales and about 20 percent of its total sales. Amey Chalke, an analyst at HDFC Securities, told Bloomberg Quint, “The warning letter will mean future approvals will be halted. It will be difficult for Lupin to offset the slowdown in Glumetza and Fortamet with this move.” This was echoed by Surajit Pal , an analyst with Prabhudas Lilladher, who told Bloomberg Quint, “Don’t see an immediate impact on earnings as existing products can be sold. Issue will be with pipeline that will now get affected.” The brokerage firm Edelweiss Securities wrote in a note, “The Goa facility is the most important facility with the highest pending approvals. This is a big negative for the company…. The warning letter will not only delay new approvals, thus impacting U.S. revenues, but also increase remediation cost that will put pressure on margins. We will revisit our earnings estimate.” Most recently, on Nov. 2, Lupin announced it had launched Doxycycline Hyclate Tablets USP, 75 mg and 150 mg after receiving approval from the FDA. They are a generic version of Aqua Pharmaceuticals ’ Acticlate Tablets for the treatment of infections caused by various bacteria and as an adjunctive therapy in severe acne. Lupin reports about $2.55 billion (US) in annual revenues and is one of the largest generic pharmaceutical company globally by market cap.