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Alembic Pharma in spotlight after unit gets USFDA approval for drug

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Alembic Pharmaceuticals announced after trading hours yesterday, 12 February 2019, that its wholly-owned step-down subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc. (AbbVie).

Fenofibrate Tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia.

Fenofibrate Tablets USP, 54 mg and 160 mg have an estimated market size of $92 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 85 ANDA approvals (72 final approvals and 13 tentative approvals) from USFDA.

Dewan Housing Finance Corporation announced that Mrs. Vijaya Sampath an independent director on the board of the company, has resigned due to personal reasons. The board has accepted her resignation with effect from 12 February 2019. The announcement was made after trading hours yesterday, 12 February 2019.

The Reserve Bank of India (RBI) has imposed, by orders dated 31 January 2019, monetary penalty on Allahabad Bank, Bank of Maharashtra, Indian Overseas Bank and Andhra Bank for non-compliance with various directions issued by RBI on monitoring of end use of funds, exchange of information with other banks, classification and reporting of frauds, and on restructuring of accounts.

While Allahabad Bank, Bank of Maharashtra and Indian Overseas Bank have been fined Rs 1.5 crore, Andhra Bank has been fined Rs 1 crore. These penalties have been imposed taking into account failure of the above banks to adhere to the aforesaid directions issued by RBI. This action is based on deficiencies in regulatory compliance and is not intended to pronounce upon the validity of any transaction or agreement entered into by the banks with their customers.

Lumax Auto Technologies announced after trading hours yesterday, 12 February 2019, that the newly set-up unit of the company situated at Aurangabad in Pune has started commercial production/supply from 12 February 2019. This unit has been set-up to manufacture and supply chassis frame, swing arm and trail arm to its customer, Bajaj Auto. The unit has been setup with a capacity of about 700,000 annually.

Housing and Urban Development Corporation (HUDCO) announced after trading hours yesterday, 12 February 2019, that it has achieved loan sanctions of Rs 15581.24 crore and loan releases of Rs 15534.37 crore (release against previous year sanction is Rs 7942.06 and release against current year sanction is Rs 7592.31), as on 31 January 2019, for the financial year 2018-2019.

Lakshmi Machine Works announced after trading hours yesterday, 12 February 2019, that during the financial year 2019-20, it is expected to commence assembly of machine tools for DMG Mori Co., Japan and supply the same to DMG Mori India. Based on the orders placed by DMG Mori India, the assembly of machine tools will happen at the company's existing machine tool division facility located in Coimbatore. It is further informed that this activity will not involve any capital expenditure.

L&T Technology Services (LTTS) announced after trading hours yesterday, 12 February 2019, that a client in the telecom & hitech reporting segment, has decided to assume ownership of engineering for their core product. Other engagements with this client continue and LTTS is in discussions to partner with the client in multiple adjacent areas, as they look to invest and expand their business. On account of this development, LTTS' annualized revenue will be impacted by around 4% starting March 2019, with no material change to the EBITDA margin. Notwithstanding the above, LTTS reaffirms its FY2019 revenue guidance and its expectation of mid-teens revenue growth in FY2020 in USD terms.

Tata Power Company announced after trading hours yesterday, 12 February 2019, that its wholly-owned subsidiary, Tata Power Solar Systems, has launched a complete residential rooftop solution in Chandigarh. The residential rooftop solutions are expected to save up to Rs 50,000 annually for 25 years.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, February 13 2019. 08:30 IST
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