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Lupin in spotlight after getting USFDA nod to sell generic drugs

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Last Updated : Mar 07 2014 | 9:45 PM IST

Lupin after market hours on Thursday, 6 March 2014, announced that it has received final approval for its Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Aqua Pharmaceuticals Monodox Capsules 50 mg, 75 mg, and 100 mg. Lupin's Doxycycline Capsules 50mg, 75mg and 100mg are the AB-rated generic equivalents of Aqua Pharmaceuticals, LLC's Monodox Capsules 50mg, 75mg and 100mg and are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne.

The company also received final approval from the FDA for its Ciprofloxacin for Oral Suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) to market a generic version of Bayer HealthCare Pharmaceuticals, Inc.'s (Bayer) Cipro for Oral Suspension 5 g/100 mL and 10 g/100 mL, Lupin said. Lupin's Ciprofloxacin Oral Suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) is the generic equivalent of Bayer's Cipro Oral Suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) and indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations.

Lupin is the first applicant to file an ANDA for Cipro Oral Suspension 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the products shortly, Lupin said in a statement.

Monodox Capsules had annual US sales of $180.6 million (IMS MAT Dec, 2013) whereas Cipro Oral Suspension had annual US sales of $8.6 million (IMS MAT Dec, 2013).

Zee Entertainment Enterprises after market hours Thursday, 6 March 2014, said that the company has issued and allotted 20,169,423,120 - 6% Cumulative Redeemable Non-Convertible Preference Shares (Bonus Preference Shares) of Re 1 each fully paid as bonus to the company's equity shareholders as on record date i.e. 4 March 2014, in ratio of 21 bonus preference shares for every 1 equity share held in the company.

Merrill Lynch Capital Markets Espana bought an additional 2.64 lakh shares, or 0.57% equity, of Financial Technologies (India) (FTIL), as per bulk deal data available with the stock exchanges. The shares were purchased on NSE at an average price of Rs 370.07, valuing the transaction at Rs 9.77 crore. However, identity of seller of the shares could not be ascertained.

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On Wednesday, 5 March 2014, Merrill Lynch Capital Markets Espana bought 2.35 lakh shares, or 0.51% equity, in FTIL. The shares were purchased at an average price of Rs 347.76.

Central Bank of India said that after due approval, it has sold its entire stake in Credit Information Bureau of India (CIBIL) to Transunion International Inc (FII).

Hinduja Ventures said that Grant Investrade, a wholly owned subsidiary of the company, has been granted the permission for providing HITS (Headend-In-The-Sky) Services by Ministry of Information and Broadcasting.

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First Published: Mar 07 2014 | 8:53 AM IST

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