Lupin share price rose in the early trade and touched 52-week high of Rs 991.45 after the company received correspondence from the USFDA that it has now addressed the concerns raised in the warning letter for its facilities in Goa and Pithampur Unit-2, Indore.
At 09:31 hrs Lupin was quoting at Rs 981.00, up 0.10 percent on the BSE.
The US FDA correspondence comes after the satisfactory evaluation of the corrective actions taken by the company in response to the warning letter that was issued by the US regulator on November 6, 2017.
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On July 26, the company's wholly-owned subsidiary in Australia, Generic Health Pty Ltd, received approval for Tiotropium 18 micrograms powder for inhalation in capsules for use with LupinHaler, its bioequivalent version of SPIRIVA tiotropium powder for inhalation from the Therapeutic Goods Administration (TGA). The product will be manufactured at Lupin’s Pithampur facility in India.
The company incorporated another wholly-owned subsidiary, Lupin Manufacturing Solutions Limited, for undertaking contract development and manufacturing activities.
A meeting of the board of directors of the company will be held on August 3, 2023, to consider and take on record the unaudited financial results of the company for the quarter ended June 30, 2023.
On July 12, the company received Form-483 with two observations after the USFDA inspected its Nagpur oral solid dosage facility from July 3 to July 11,
2023.
On July 14, the company's subsidiary, Lupin Inc., based in Somerset, New Jersey, received USFDA approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
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