After reporting multiple approvals and developments in the past few days, Zydus Lifesciences Ltd has experienced a surge in its share price during trading sessions. Today, the company has reached a fresh 52-week high at Rs 531.30. Yesterday script closed at price of Rs 517.70. Currently, it is trading at Rs 529.65, reflecting a gain of 2.31%. The company’s 52-week low stands at Rs 329.60, and its market capitalization is approximately Rs 53,500 crore.
In a regular filing submitted yesterday, the company announced that its injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent a USFDA inspection from June 5, 2023, to June 13, 2023. The cGMP inspection concluded with NIL observations, demonstrating the company’s commitment to maintaining high standards.
Here are some recent noteworthy developments within the company:
On June 7, 2023, the company informed the board about receiving final approval from the United States Food and Drug Administration (USFDA) for Tadalafil Tablets USP, 20 mg. Tadalafil is a medication that relaxes muscles in blood vessels and improves blood flow to specific areas of the body. In the United States, Tadalafil Tablets USP, 20 mg, generated annual sales of USD 61 million.
On June 8, 2023, the company also announced receiving final approval from the USFDA for Esomeprazole Magnesium for Delayed-Release Oral Suspension, available in strengths of 20 mg and 40 mg. Esomeprazole is utilized to treat various stomach and esophagus issues, including acid reflux and ulcers.
On June 9, 2023, the company declared the commencement of Phase IV Real World Data Registry trial named “EVIDENCES-XI” for Saroglitazar Magnesium in NAFLD patients with comorbidities.
On June 10, 2023, the company obtained final approval from the USFDA for Balsalazide Disodium Capsules USP, 750 mg. This medication is used for the treatment of bowel diseases such as ulcerative colitis. Balsalazide Disodium Capsules USP, 750 mg, generated annual sales of USD 29 million in the United States.
On June 13, 2023, the company received final approval from the USFDA for Varenicline Tablets, an effective treatment for smoking addiction. The drug will be manufactured at the group’s formulation manufacturing facility located in Ahmedabad SEZ, India. Varenicline Tablets, available in strengths of 0.5 mg and 1 mg, achieved annual sales of USD 501 million in the United States.
Additionally, on June 13, 2023, the company received final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets. These tablets, available in strengths of 50 mg/200 mcg and 75 mg/200 mcg, generated annual sales of USD 13 million in the United States.
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