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Indian drugmaker Lupin is facing delays in expanding its presence in the U.S. market after an FDA inspection uncovered deficiencies at a company facility. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More
The Apothecary Shoppe’s facility in Oklahoma has been given a warning letter after an FDA inspection revealed that the firm produces potassium chloride, a drug that appears on the list of drug products that have been withdrawn or removed from the market. Read More
An FDA review into shipments of drugs from a UK company to the U.S. revealed that Wallace Cameron International has not fulfilled its establishment registration and drug listing obligations but continued to manufacture, prepare, propagate and process drugs that were exported to the U.S. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More