FDA has issued a Warning Letter to Novartis for cGMP violations at its manufacturing facility for finished pharmaceuticals in Unterach, Austria. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009. The Warning Letter was issued based on an inspection of the.
The Warning Letter was issued based on an inspection of the facility from Oct. FDA cited the company for failing to obtain FDA’s approval of changes in the quality controls established in an approved application prior to distributing a product with those changes. 15–23, 2012 at which FDA noted several violations of cGMP in the company’s quality control unit. The agency noted that the company manufactured and distributed finished parenteral drugs to the US market using unapproved procedures for visual inspection prior to obtaining approval of a supplement regarding these changes.
The agency said “the procedures established to perform the visual inspection of critical defects, such as particulate matter in finished parenteral drug vials, are inadequate in that operators following these procedures have repeatedly failed to detect visible particles.” The agency said that on at least 10 occasions, the company’s inspection of finished-product vials failed to detect visible particle material.
Executive Summary. Sandoz/Momenta's generic of Teva's 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer's McPherson, Kan., plant put review on hold. Already Registered? Sign in to continue reading. Sign In. Thanks, we've sent a link to reset.
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Subject: Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch.
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L. ast month, Novartis disclosed that it received a warning letter from the Food and Drug Administration about manufacturing issues at two facilities in India that are operated by its Sandoz generic drug unit. At the time, the company noted it was working closely with the FDA to resolve the problems.
“We take the health authority inspection outcomes seriously and have been working diligently on corrective actions at the Kalwe and Turbhe sites in India since the inspections last year, and continue to keep the FDA updated on our actions,” he said. UPDATE: A Novartis spokesman wrote us to say that the drug maker is in the process of updating various systems to better track data. FDA Novartis Sandoz By Ed Silverman By Ed Silverman advertisement By Ed Silverman By Ed Silverman By Ed Silverman.
A key issue that alarmed the agency during its August 2014 inspections was the integrity of the data Sandoz was collecting.
US drugmaker Momenta Pharmaceuticals (Nasdaq: MNTA), whose shares were halted at $19 after hours on Friday, following its announcement that Sandoz's contracted fill/finish manufacturing partner, US pharma giant Pfizer (NYSE: PFE), has received a US Food and Drug Administration warning letter.
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Copaxone FDA Warning Letter Focus On Generics Glatopa Momenta Pharmaceuticals Musculoskeletal Neurological Novartis Pfizer Pfizer facility Production Regulation Sandoz US FDA USA.
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Momenta Pharmaceuticals announced that Sandoz’s contracted fill/finish manufacturing partner has received…
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"We are fully committed to work with Sandoz and Pfizer to resolve the recently announced warning letter," Momenta Pharmaceuticals President and CEO Craig Wheeler said in a statement on Tuesday. Glatopa is a generic version of Copaxone, an injection by Teva Pharmaceutical used to treat patients.
—Reuters contributed to this report.
In a release on Friday, the Cambridge, Massachusetts-based company said that Pfizer has indicated that the letter does not restrict the production or shipment of the 20 mg dose of Glatopa, a product that is currently marketed by partner Sandoz in the U.S.
Glatopa is a generic version of Copaxone, an injection by Teva Pharmaceutical used to treat patients with relapsing forms of multiple sclerosis.
The company's announcement came ahead of its better-than-expected fourth-quarter earnings results. The company posted earnings of 60 cents per share on revenue of $34.2 million on Tuesday.
biotechnology company Momenta Pharmaceuticals plunged on Tuesday after the firm said Pfizer, a key supplier for its multiple sclerosis drug, has received a warning letter from the Food and Drug Administration. Shares of U.S.
"We are fully committed to work with Sandoz and Pfizer to resolve the recently announced warning letter," Momenta Pharmaceuticals President and CEO Craig Wheeler said in a statement on Tuesday.
The approval of Glatopa 40 mg, ANDA, will be dependent on the resolution of Pfizer facility compliance issues.
The company said approval in the first quarter of 2017 is "unlikely.".
Analysts expected the company to report a loss of 24 cents per share on revenue $22.4 million, according to Thomson Reuters consensus estimates.
Momenta's stock shed 15.5 percent on Tuesday, ending the day at $16.05 per share.
Despite Tuesday's losses, the stock is up more than 6 percent year to date.