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Biocon in focus after Bengaluru facility receives EIR from USFDA

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Biocon announced that has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its sterile drug product manufacturing facility in Bengaluru, following the USFDA pre-approval inspection of this facility in April/ May 2018. EIR notified that the inspection stands closed. The announcement was made on Saturday, 23 June 2018.

Unichem Laboratories clarified that it filed an Abbreviated New Drug Application (ANDA) with Para IV certification for generic Tadalafil with the US Food and Drug Administration (USFDA). Pursuant to the said filing Eli Lilly & Company and the ICOS Corporation filed an infringement suit against the company in the United States District Court for the District of New Jersey seeking to prevent the company from launching its generic Tadalafil in the United States of America. The parties then mutually negotiated a settlement of the action under which Unichem may launch its generic Tadalafil in the United States on or not before 26 March 2019. No other claims have been filed against the company.

 

In terms of the settlement, the company shall pay to Eli Lilly, a royalty of 5% on net sales of the product up till the expiry of the US patent, i.e. 26 April 2020. There is no other compensation or penalty payable, other than Royalty mentioned above. The announcement was made after market hours on Friday, 22 June 2018.

Symphony announced that it has signed an agreement to effectively purchase 95% equity stake in Climate Technologies, Australia's leading manufacturer of cooling and heating appliances. The acquisition will be executed at a valuation range of 40-44 million Australian dollars (Rs 201 - 221 crore) depending on the achievement of FY18F EBITDA (June ended). Further, the valuation is subject to change based on customary closing conditions. The company plans to finance the acquisition through a judicious mix of debt and internal cash accruals. Headquartered in Adelaide, South Australia, Climate Technologies manufactures and sells evaporative air coolers, ducted gas heaters, and other cooling products in Australia and USA. The announcement was made after market hours on Friday, 22 June 2018.

Phoenix Mills announced that it has acquired an under-construction retail asset in Indore. It acquired the asset for Rs 234 crore in an auction conducted by an asset reconstruction company. This brownfield expansion will add approx. 1.1 million square feet to Phoenix Mills' retail asset portfolio. The site offers a further development potential of approximately 800,000 square feet. The announcement was made after market hours on Friday, 22 June 2018.

Indian Hotels Company will be watched. With reference to news item titled "Taj Acquires Lutyen's Delhi Hotel Through NDMC Auction", Indian Hotels Company clarified after market hours on Friday, 22 June 2018, that it has not acquired The Connaught hotel as the property belongs to NDMC. The company had participated in an e-auction conducted by NDMC on 20 June 2018 for grant of licensing rights to operate the hotel. While NDMC has declared that the company is the successful bidder, the letter of award from NDMC is awaited, neither the company has entered into any agreement with NDMC. Accordingly, the company has currently nothing further to comment or disclose with respect to matters appearing in the news report.

Wheels India announced that its board recommended bonus issue of equity shares in the ratio of 1 equity share of Rs 10 each for every 1 equity share of Rs 10 each held by the shareholders of the company as on the record date, subject to the approval of the shareholders. The company has fixed 9 August 2018 as the record date for the bonus issue. The announcement was made after market hours on Friday, 22 June 2018.

City Union Bank said that its board fixed 11 July 2018, as the record date for reckoning the eligible shareholders for bonus allotment subject to shareholder approval through postal ballot/e-voting.

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First Published: Jun 25 2018 | 8:10 AM IST

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