The US drug regulator has raised concerns over Lupin's Pithampur facility in Madhya Pradesh, the Indian pharma company said in a statement on Monday.
The US drug regulator has raised concerns over Lupin's Pithampur facility in Madhya Pradesh, the Indian pharma company said in a statement on Monday.
The Mumbai-based drugmaker said its manufacturing facility at Pithampur, near Indore were issued Form 483 by the US Food and Drug Administration (FDA).
The Pithampur and its other facility, Lupin Bioresearch Center (LBC), Pune were audited in November 2014 and January 2015, respectively.
"Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483s)," it said in the statement.
US FDA issues Form 483 to a pharma company if it observes any conditions in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The companies are encouraged to take corrective action.
While Lupin did not disclose the nature of the observations, they are likely to be procedural in nature and should not have any significant impact, feel industry experts.
Sarabjit Kour Nangra, VP research - pharma, Angel Broking, said, "While currently the details of the observations are not known, though should not be serious given that the company has got approvals after the observation.
Hence we are not changing our estimates, though the material impact of the damage should not be high."
Shares of the company fell over 5% on BSE on Monday before closing at Rs 1,648.70 apiece, down 2.5% the previous close.
However, the company said that since the audit the Indore facility has received one abbreviated new drug application (ANDA) approval and two-site transfer approvals. Lupin said it has received final approval from the US drug regulator for its Bimatoprost Ophthalmic Solution, 0.03% to market a generic version of Allergan Inc's Lumigan Ophthalmic Solution, 0.03%. The filing of the drug was made from the Indore facility.
Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Nangra of Angel Broking, said,"The product has more than $500 million sales in US, with only Apotex being the other player in the market. Thus the product can contribute well for company's US sales in 2015-16. In fiscal 2016, the company can garner sales of $50-80 million in sales for the company."
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