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The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More
Dr. Reddy’s Laboratories is the latest Indian drugmaker beset by quality problems after recalling 58,650 bottles of the generic heartburn drug lansoprazole due to contamination. Read More
Drugmakers should test porcine trypsin, a starting material used in biologic drugs, just after it is produced to ensure material from a single infected pig doesn’t enter production batches, the European Medicines Agency says. Read More
The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
Baxter and Sagent Pharmaceuticals are the latest generic drugmakers to recall products with leaky containers, notifying healthcare providers that affected product may be contaminated with particulates. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say. Read More