Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
Lacosamide Injection is used to treat partial-onset seizures.
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
The drug will be manufactured at the group’s topical facility at Ahmedabad
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
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