Lupin plant clears US FDA hurdle

Lupin’s key manufacturing plant in Mandideep cleared what could have become a hurdle, after it addressed concerns raised earlier by the drug regulator. Earlier, the US drug regulator had issued a warning letter to the company for its cephalosporins facility, asking it to rectify deficiencies or face action. Unlike Ranbaxy Laboratories, Lupin’s drug supplies to the US were not affected.

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DIL sells drug discovery and development services subsidiary to Evotec AG

DIL is selling a 70% stake in its contract research subsidiary to a European company Evotec AG, headquartered in Germany. DIL was earlier known as Duphar Interfran and it changed its name after its pharmaceutical business was hived off to Solvay. Of its consolidated turnover of Rs 70 crore in 2008-09, bulk drugs/chemicals contributed to over half, while research and development contributed to about a third at Rs 22 crore.
 

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Caraco claims sound financial position, but FDA action will harm performance

Caraco issued a statement on Friday, clarifying its financial position after the FDA raid on its facilities. The company said that the inventory that has been seized by the regulator has a value of about $15-$20mn. It does not affect products sold by Caraco under third-party distribution agreements (such as with Sun Pharmaceutical Industries, its Indian parent company) and also products sold under the Caraco brand, but made by other companies.

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FDA sidewinder hits Caraco, Sun Pharma suffers collateral damage

Caraco Pharmaceutical Laboratories, a 74% subsidiary of Sun Pharmaceutical Industries, has come under fire from the FDA. American enforcement officials raided Caraco’s plants, seized medicines and ingredients used in their production. The seizure has been attributed to Caraco’s continued failure to meet cGMP norms (current good manufacturing practices). The FDA had warned Caraco in October 2008 and had given it time to rectify the deficiencies.

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Novartis revises open offer price by 28% to Rs 450

Novartis AG has offered Novartis India’s shareholders Rs 99 more per share to make its open offer more attractive. The promoter holding in Novartis will increase to 89.93%, if the offer succeeds, just below the 90% cap on promoter holding in a listed company. The current share price is Rs 444 and it remains to be seen how many shareholders tender, even at the revised price of Rs 450. The price had touched a high of Rs 467 indicating investors were expecting the revised price to be higher.

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Pfizer to raise stake in Pfizer India to 75%; is delisting on the cards?

Pfizer Investment Netherlands BV, a subsidiary of Pfizer Inc, will pay Rs 675 a share to acquire a 33.77% stake in Pfizer India. At this price, the total consideration is Rs 680 crore and Pfizer’s stake will go up to 75%. It will take regulatory approvals for the open offer. Pfizer will have to revise its offer price for the open offer to succeed, as the current market price is already Rs 685. It would have known it may not get many buyers at this price. But it expects the offer to open only in June 2009, so it has used the prevailing price to arrive at a floor.

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Taro Pharma rejects Sun Pharma’s offer, proposes a shareholder referendum on the offer price

Taro Pharmaceutical Industries has rejected Sun Pharmaceutical’s revised offer price (disclosed yesterday by Sun Pharma) as too low. It has said that Sun Pharma rejected its offer of a face to face meeting, made on December 30, and instead chose to go public with the offers, which were to be confidential. Apparently, Sun Pharma refused to meet unless Taro made a counter offer first.
 

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