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Alembic Pharma Gets USFDA Nod For Pain Relief Ointment; What Should One Do..??

Alembic Pharma gets USFDA nod for pain relief ointment; what should one do..??

Alembic Pharmaceuticals today said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for Xylocaine ointment, used for temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites.

“Aleor Dermaceuticals has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lidocaine ointment USP, 5%,” Alembic Pharmaceuticals said in a BSE filing.

Alembic Pharmaceuticals Ltd is India’s leading pharmaceutical company, vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates. Alembic is the market leader in the Macrolides segment of anti-infective drugs in India. Alembic Pharmaceuticals presents an extensive range of branded and generic formulations, in compliance with international and national regulations. The plant at Vadodara has the largest fermentation capacity in India. API’s makes up a significant part of the operations for Alembic Pharmaceuticals. It has an exclusive facility for manufacturing synthetic APIs, consisting of independent manufacturing blocks for Macrolides, NSAIDs and other drugs. Alembic Pharmaceuticals is also present in the Nutraceuticals business for last 50 years.

Quoting IQVIA data, Alembic Pharmaceuticals said Lidocaine ointment has an estimated market size of USD 97 million for twelve months ending December 2017. Alembic has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from USFDA, including this first ANDA approval for Aleor.

Alembic

Attached is the monthly chart of Alembic Pharma that shows price action restricted within the parallel channel pattern for the past 3 year after it peaked at 791.70 in July 2015. The low degree corrective move that has occurred after a strong rally has sustained above 38.2% retracement of the overall advance. There was a large selloff that short lived towards 50% retracement. Recently stock was seen resisting at the upper end of the pattern and downward move has already started. Momentum indicators have failed to show any sign of bullishness as RSI found resistance at 60 with DI lines trading below neutral territory and thus indicates low volatility breakout in happening. Thus, Supports at 500 and resistance at 660 will be closely watched for follow-up action and trade opportunity.

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  1. Alembic Pharma gets USFDA nod for insomnia treatment drug
    Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for Temazepam capsules, used for treatment of insomnia. The company has got approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing. The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules.

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