India-based Sun Pharmaceutical Industries Ltd has made announcement that the company along with its arm, has got first U.S. Food and Drug Administration sanction to market the generic version of a controlled substance in tablet form.
According to sources, the company is allowed to sell generic hydrocodone bitartate with acetaminophen in multiple strengths, which has a U.S. market size of $540 million for branded and generic versions.
The US Food and Drug Administration (USFDA) has given its final approval to Matrix Laboratories to market Stavudine capsules in two different potencies including 30 mg and 40 mg.
Stavudine, an analog of thymidine, is a nucleoside analog reverse transcriptase inhibitor (NARTI), which is active against the human immunodeficiency virus (HIV). It is prescribed for combating HIV-1 infection together with other antiretroviral agents.
The largest Indian drug maker, in terms of market value, Sun Pharmaceutical Industries Ltd has started initiatives to end acquisition dispute of Taro Pharmaceutical Industries Ltd. The company has offered to raise purchase price of stake to close the deal out of court.
The US Food and Drug Administration (FDA) can take more time to approve Ranbaxy's generic version of GSK's anti-migraine medicine, Imitrex. The delay may cause potential loss of Rs 300 crore to the drug major. Research Analyst Ranjit Kapadia said, "Since, Ranbaxy has not been able to launch the drug in the US and patent for the drug is also going to expire in February 2009, the company may have to suffer a potential revenue loss of Rs 240-250 crore in the current year."
Pharmaceutical company Strides Acrolab has announced receipt of two ANDA approvals for Sterile vancomycin in HCL USP 500mg and 1g per vial and sterile Vancomycin HCI USP 5g per vial pharmacy bulk package.
The products are licensed to Akorn-Strides,LLC, which is a joint venture that was formed in 2004 by Akorn Inc. and Strides Arcolab Limited.
Piramal Healthcare has acquired New York-based Minrad International, a manufacturer of generic inhalation anaesthetic drugs for $40 million.
Under the arrangement, the shareholders of Minrad will receive $0.12 a share in cash and Piramal will also acquire Minrad's 8 per cent senior secured convertible notes from the note holders.
India-based Sun Pharmaceutical Industries Ltd has made announcement that the company along with its arm, has got first U.S. Food and Drug Administration sanction to market the generic version of a controlled substance in tablet form.
The US Food and Drug Administration (USFDA) has given its final approval to Matrix Laboratories to market Stavudine capsules in two different potencies including 30 mg and 40 mg.
The largest Indian drug maker, in terms of market value, Sun Pharmaceutical Industries Ltd has started initiatives to end acquisition dispute of Taro Pharmaceutical Industries Ltd. The company has offered to raise purchase price of stake to close the deal out of court. 
The US Food and Drug Administration (FDA) can take more time to approve Ranbaxy's generic version of GSK's anti-migraine medicine, Imitrex. The delay may cause potential loss of Rs 300 crore to the drug major. Research Analyst Ranjit Kapadia said, "Since, Ranbaxy has not been able to launch the drug in the US and patent for the drug is also going to expire in February 2009, the company may have to suffer a potential revenue loss of Rs 240-250 crore in the current year." 
Pharmaceutical company Strides Acrolab has announced receipt of two ANDA approvals for Sterile vancomycin in HCL USP 500mg and 1g per vial and sterile Vancomycin HCI USP 5g per vial pharmacy bulk package. 
Piramal Healthcare has acquired New York-based Minrad International, a manufacturer of generic inhalation anaesthetic drugs for $40 million. 
