 "US FDA grants approval to Granules India for ibuprofen tabs")
The US Food & Drug Administration (FDA) has granted the Hyderabad-based Granules India Ltd an abbreviated new drug application (ANDA) for ibuprofen tablets USP 400 mg, 600 mg and 800 mg.
C Krishna Prasad, chairman & managing director, Granules India, said, "It's my pleasure to state that US FDA completed the review of ibuprofen ANDA filed by us and has given its final approval. It will further strengthen our base business and enable us to increase our products offering to our customers in USA."
Granules is one of the few companies in the world to be present across the pharmaceutical manufacturing value chain starting from active pharmaceutical ingredients (APIs) through pharmaceutical formulation intermediates (PFIs) to finished dosages (FDs). The company offer our customers all three components of the pharmaceutical manufacturing value chain to enhance flexibility and efficiency.
Granules India has three facilities in Hyderabad and a fourth facility in Jingmen, China. It is also setting up a fifth factory in Vizag through its JV company, Granules OmniChem. It is among the global leaders in manufacturing paracetamol, ibuprofen, metformin, guaifenesin and methocarbamol.
C Krishna Prasad, chairman & managing director, Granules India, said, "It's my pleasure to state that US FDA completed the review of ibuprofen ANDA filed by us and has given its final approval. It will further strengthen our base business and enable us to increase our products offering to our customers in USA."
Granules is one of the few companies in the world to be present across the pharmaceutical manufacturing value chain starting from active pharmaceutical ingredients (APIs) through pharmaceutical formulation intermediates (PFIs) to finished dosages (FDs). The company offer our customers all three components of the pharmaceutical manufacturing value chain to enhance flexibility and efficiency.
Granules India has three facilities in Hyderabad and a fourth facility in Jingmen, China. It is also setting up a fifth factory in Vizag through its JV company, Granules OmniChem. It is among the global leaders in manufacturing paracetamol, ibuprofen, metformin, guaifenesin and methocarbamol.