Lupin’s U.S. subsidiary, Lupin Pharmaceuticals Inc., has got approval to sell the generic form of an anti-diabetes drug (for type II diabetes) in the U.S. market. Currently, specialty biopharmaceutical company Santarus Inc. holds the right to market the patented drug Glumetza HCL ER in the U.S. market, the generic form of which (Metformin Hydrochloride extended release tablet) Lupin will market in dosages of 500 mg and 1000 mg. Continue Reading →
Sun Pharma
Recent Posts
Dr Reddy’s and Fresenius Kabi get US FDA approval for generic Femara
|
The US Food and Drug Administration gave approval to Dr Reddy’s Laboratories and Fresenius Kabi Oncology, both listed Indian pharmaceutical companies, to market cancer drug letrozole or the generic version of Femara in the US. Novartis owns the patent for Femara, a drug used to treat breast cancer in post-menopausal women, which earned US-market sales of $682 million or Rs 3,100 crore in 2010.
Filed under: Companies, Quick News, Dr Reddy's Laboratories, Fresenius Kabi Oncology, Natco Pharma, Sun Pharma
Sun Pharma receives USFDA approval for ophthalmology product
|
The USFDA has granted an approval for Sun Pharma to start selling the generic version of Acular, ketorolac tromethamine ophthalmic solution, 0.5%.
Ketorolac tromethamine ophthalmic solution is prescribed to provide temporary relief of ocular itching due to seasonal allergic conjunctivitis, and also in treating post-operative inflammation in patients who have undergone cataract extraction.
Acular, a licensed medication of US-based Allergan, has annual sales of $40 million a year in the US.
Filed under: Companies, Quick News, Acular, Ketorolac tromethamine, ophthalmology, Sun Pharma, USFDA
Sun Pharma to revise guidance after FDA’s raid on Caraco
|
Dilip Shanghvi, chairman and managing director, Sun Pharmaceutical Industries, and Sudhir Valia, director held a conference call held to discuss the FDA raid on its US subsidiary Caraco Pharmaceutical Laboratories. This event has come as big blow for Sun. It has withdrawn its current guidance and will issue a revised one, in due course. The issue is expected to have a significant short term impact on Caraco and some adverse impact on Sun’s short term performance too.
Filed under: Companies, Top News, Caraco, Conference Call, FDA, Sun Pharma
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. Continue Reading →
Filed under: Companies, Quick News, Caraco, Pharmaceutical, Sun Pharma
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. Continue Reading →
Filed under: Companies, Top News, Caraco, Companies Disclosures, Companies International, FDA, Pharmaceutical, Sun Pharma
Sun Pharma requests a judgement from Israel’s Supreme Court
|
Sun said, in a SEC filing, it has extended the tender offer closing date from Jan 9 to Jan 30. It also said that it has informed the Supreme Court that its negotiations to reach a settlement have been unsuccessful. It is now awaiting the court’s decision in the matter. The dispute concerns the price at which Sun will acquire Taro’s shares from promoters and minority shareholders. Initially, Sun had offered $7.75 a share, which it then hiked to $9.50 a share, but Taro responded first with an offer to conduct a shareholder referendum to decide the price. Continue Reading →
Filed under: Companies, Top News, Companies International, M&A, Open Offer, Sun Pharma, Taro
Sun Pharmaceuticals refuses Taro’s $15 a share offer
|
Sun Pharmaceuticals has sent a letter to the stock exchange, rejecting the offer put forth by Taro proposing $15 a share in the tender offer. In a letter, in what has now become routine, Sun Pharmaceuticals rejects the referendum proposal. It also addresses Taro’s latest offer of taking the merger price up to $15 a share.
Filed under: Companies, Quick News, M&A, Open Offer, Sun Pharma, Taro
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.
Filed under: Companies, Top News, M&A, Pharmaceutical, Sun Pharma, Taro
What made the US FDA issue a warning letter to Sun Pharma’s subsidiary Caraco?
|
The US FDA had issued a warning letter to Sun Pharma’s subsidiary Caraco Pharmaceutical Laboratories on Oct 31, 2008. The letter is now available on the FDA site detailing the reasons why the warning was issued. It points out deviations from current Good Manufacturing Practice (CGMP) regulations for medicines. These deviations were detected in an inspection between May 1 to June 11 2008, and are mainly due to issues related to quality control. Continue Reading →