Lupin Share Gains on USFDA Tentative Approval of Valbenazine Capsules

UK MHRA completes inspection of Lupin's Pithampur facility.

Shares of Lupin rose 2% intraday on March 27 after the drugmaker received preliminary approval from the US Food and Drug Administration (USFDA) for Valbenazine capsules.

Lupin’s Abbreviated New Drug Application (ANDA) for Valbenazine Capsules (40 mg, 60 mg and 80 mg) Receives Preliminary Approval for Marketing Biosciences Inc, according to a press release.

Annual US sales of Valbenazine Capsules are estimated at $1,235 billion.

On March 25, the company announced the successful completion of an inspection by the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) at its Pithampur, India facility. Inspections are from March 20 to March 24, 2023.

Lupin Managing Director Nilesh Gupta said: “Combining oral solids, inhalation, dermatology, high potency and oral contraceptive products, this is a vital facility that must maintain the highest quality standards and compliance.”

Lupin also announced that the USFDA has completed a post-marketing adverse drug reaction (PADE) inspection of the company’s operations. No observations were made at the end of the inspection.

Lupin shares were quoted at Rs 659.10 at 10:12 am, up nearly 3% on the NSE.

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