Indian and Chinese manufacturers receive warnings from CDER


The Center for Drug Evaluation and Research department of the FDA issues warning to the Indian based active pharmaceutical ingredient (API) manufacturer CTX Life sciences Private Ltd. and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co, with two warning letters.

The warning to the Indian based pharmaceutical brand was issued considering the recklessness shown by the firm towards ensuring if the water used for the parenteral grade APIs was suitable for its intended use. On the other hand, the Chinese manufacturer, Ningbo Pulisi, was accused of showing negligence and failure for not having adequate equipment to test the active ingredients in their regular products, such as Anti-Dandruff Shampoo and Oil-Free Acne Wash, before its release in the market.