Glenmark Pharmaceuticals has received the EIR (Establishment Inspection Report) for its Ankleshwar plant. The EIR is issued by the US Food and Drug Administration (USFDA) only if it finds the facility to be deemed acceptable.
The company has recently has received USFDA clearance for its Investigational New Drug (IND) application to begin a Phase 2 study of GSP 304 (tiotropium bromide) for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).
Glenmark Pharmaceuticals is a global innovative pharmaceutical company with operations in more than 80 countries. It has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology.
