Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in a newly published rebuke by the U.S. FDA. In a warning letter dated Feb. 26 ...
The FDA issued Granules India three observations following a recent preapproval inspection at the Indian drugmaker’s U.S. facility. FDA officials inspected the Chantilly, Virginia, plant from Jan. 24 ...
The Preparation of Spherical Granules by Extrusion/Spheronization without Microcrystalline Cellulose
The process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when ...
The shares of Granules India crashed over 8 percent on February 28 after the company announced that it has received a warning letter from the US Food and Drug Administration (FDA) for its Gagillapur ...
Nov 13 (Reuters) - Paracetamol maker Granules India (GRAN.NS), opens new tab reported a 34% jump in its second-quarter profit on Thursday, driven by strong demand in its key European and North ...
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