Glenmark receives USFDA nod for Baddi plant
Glenmark Pharmaceuticals has received US Food & Drug Administration approval for its Baddi plant in Himachal Pradesh, which makes semi-solids (ointments and creams).
By INDIATIMES NEWS NETWORK |
MUMBAI: Glenmark Pharmaceuticals has received US Food & Drug Administration approval for its Baddi plant in Himachal Pradesh, which makes semi-solids (ointments and creams). The plant recently received GMP approval from MHRA of UK and from TPD of Canada.
The approval will enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world. It envisages the launch of a basket of products in skin care treatment in the US and in EU markets.
“Other plants of the company at Ankleshwar and Goa are already approved by these agencies,” said Glenn Saldanha, CEO and MD of the Glenmark Pharma.
The fully commissioned Baddi facility produces over Rs 230 crore worth of products. The unit currently caters to the Indian requirements and has produced batches for filing in the US and Europe. The company expects the Baddi facility to break-even in its first two years of operation.
At 12:06 pm, Glenmark shares were down 0.73 per cent at Rs 495.25 on BSE, in line with the weakness in the market.
The approval will enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world. It envisages the launch of a basket of products in skin care treatment in the US and in EU markets.
“Other plants of the company at Ankleshwar and Goa are already approved by these agencies,” said Glenn Saldanha, CEO and MD of the Glenmark Pharma.
The fully commissioned Baddi facility produces over Rs 230 crore worth of products. The unit currently caters to the Indian requirements and has produced batches for filing in the US and Europe. The company expects the Baddi facility to break-even in its first two years of operation.
At 12:06 pm, Glenmark shares were down 0.73 per cent at Rs 495.25 on BSE, in line with the weakness in the market.
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