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Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
Distributors of active pharmaceutical ingredients in Europe should build quality management systems that include the same features as drugmakers’ QMS in areas such as contamination control and documentation, according to a new reference guide on good distribution practices. Read More
The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. Read More
The FDA has issued a warning letter to Sanum-Kehlbeck for using the same equipment to produce penicillin and non-penicillin products and other quality violations. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More