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The FDA hit the Dongying Tiandong Pharmaceutical Co. with a warning letter for failing to investigate and document out-of-specification results when testing drug batches as well as GMP violations. Read More
After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
Antera Therapeutics has drawn FDA scrutiny for marketing and selling Aralyte, a kit of capsules filled with liquid peanut protein, as a preventative treatment to keep children from developing peanut allergies. Read More
The FDA rejected Spectrum Pharmaceuticals’ Qapzola, a treatment for non-muscle invasive bladder cancer, the company said following receipt of a CRL. Read More