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Ipca hit by US FDA import alert for its Ratlam plant

23 January, 2015

Mumbai-based Ipca Laboratories Ltd, which manufactures active pharmaceutical ingredients (APIs) and finished dosage forms, has received an import alert from the US drug regulator which effectively bans most of its products made at Ratlam unit from shipments to the world’s largest drug market.

The firm had last year received certain inspection observations by the US Food & Drug Authority (US FDA) for the same unit in Madhya Pradesh. Post that Ipca had voluntarily decided to temporarily suspend API shipments from the facility to the US till the issue is addressed.

Ipca said that this alert, however, does not apply to a set of APIs manufactured at the unit. These include hydroxychloroquine sulfate, propranolol hydrochloride, trimethoprim and ondansetron.

The import ban by the US FDA saw its share price crash 8.6 per cent to Rs 639.15 each on BSE in a strong Mumbai market on Friday.

Ipca counts a string of institutional investors in the company including private equity firms ChrysCapital and SAIF Partners besides a few sovereign wealth funds.

The mid-size pharma company is more than six decades old and has a significant presence in domestic branded formulations, global branded and generic formulations and global APIs.

For the year ended March 31, 2014, it had revenues of Rs 3,281.7 crore with net profit of Rs 478.5 crore.

(Edited by Joby Puthuparampil Johnson)


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Ipca hit by US FDA import alert for its Ratlam plant

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