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The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.
Pfizer’s Hospira has issued a voluntary recall of three lots of the painkiller hydromorphone, an injectable, due to an apparent manufacturing issue that could…
Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.
Merck KGaA, which has been rapidly building up its manufacturing and distribution capabilities in China, says it will now expand further in Asia.
China has closed thousands of manufacturing plants as it tries to reduce air pollution, and one pharma company says it has created supply problems.
After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.
The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals.
South Korea’s Samsung BioLogics reported a 56% jump in sales to $420 million (KRW 459.8 billion) for 2017, which the company attributes to boosts from two of…
The FDA has issued a warning letter for the Celltrion plant in South Korea that makes Pfizer's Remicade biosimilar, Inflectra.
An API maker in Bizen, Japan, has joined a growing list of Japanese drugmakers to be criticized by the FDA in warning letters and bans.