Search For "usfda"
Morepen Labs' net profit rises by 256 per cent led by higher APIs exports
Updated : 6 years, 7 months ago IST
New Delhi [India] August 14 (ANI/NewsVoir): Morepen Laboratories Ltd has reported a 256 per cent rise in its net profit (standalone) at Rs 8.41 crore in the first quarter (Q1) of FY 2019-20 as against Rs 2.36 crore net profit registered in the corresponding quarter of the previous fiscal.
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Indoco's Goa plant gets warning letter from USFDA
Updated : 6 years, 8 months ago IST
Mumbai (Maharashtra) [India], July 15 (ANI): Pharma company Indoco Remedies said on Monday it has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral dosages plant in Goa as a result of the inspection carried out in January.
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USFDA finds zero 483 observations and grants NAI to Centaur Pharmaceutical
Updated : 6 years, 9 months ago IST
Pune (Maharashtra) [India] June 11 (ANI/BusinessWire India): Mumbai based Centaur Pharmaceuticals' finished dosage facility in Pune was audited by the USFDA in May 2019 and the audit was concluded with NIL 483 observations.
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Jubilant Life Sciences to address USFDA concerns after warning
Updated : 7 years ago IST
Noida (Uttar Pradesh) [India], Mar 8 (ANI): Jubilant Life Sciences said on Friday that the US Food and Drug Administration (USFDA) has issued a warning letter after conducting an inspection at its manufacturing facility in Roorkee, Uttarakhand.
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Gujarat based Espee Group gets USFDA approval for their manufacturing plan
Updated : 7 years ago IST
New Delhi [India], Feb 26 (ANI): Aavis Pharmaceuticals, part of Espee Group, located in Hoschton, GA, completed an inspection by the US Food and Drug Administration at the company’s primary manufacturing facility with Zero 483 observations. With successful inspection of its formulat
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Twin USFDA approvals for Morepen Labs' bulk drugs (API) facilities
Updated : 7 years, 7 months ago IST
New Delhi [India], July 30 (NewsVoir): Morepen Laboratories Ltd. has received US FDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing facilities situated in Himachal Pradesh.
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Morepen Labs reports 107 pct increase in net profit for Q3 FY 2017-18
Updated : 8 years, 1 month ago IST
New Delhi [India], Jan 22 (ANI-NewsVoir): Morepen Laboratories Ltd has reported yet another growth-filled quarter by registering 107 per cent rise in its net profit in Q3 of FY 2017-18 at Rs. 9.67 crore, despite a marginal rise in its net sales revenue at Rs. 139.87 crore, compared to the co
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India fast emerging as inventors' hub for drugs patent
Updated : 8 years, 2 months ago IST
Chandigarh [India], Dec 24 (ANI): India is fast emerging as an inventors' hub for patents for an assortment of drugs worldwide. Around 15 per cent of the total 1.3 lakh patents filed in India from 2013 to 2015 have been contributed by the indigenous pharmaceutical industry. India is ranked
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Morepen Gets US FDA clearance for its Bulk Drug Montelukast Sodium
Updated : 8 years, 2 months ago IST
New Delhi [India], Dec 20 (ANI-NewsVoir): The United States Food and Drug Administration (USFDA) has cleared Montelukast Sodium, a bulk drug / API manufactured by Morepen Laboratories Ltd., for sale in the US market. This gives Morepen an entry into the Rs. 2000 crore (Approx. $ 300 million)
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Strides Shasun gets USFDA tentative nod for Ranitidine tablets
Updated : 8 years, 6 months ago IST
New Delhi, Aug 24 (ANI): Strides Shasun in a BSE filing today announced receiving an approval from the US health regulator for Ranitidine tablets used for treating intestinal and stomach ulcers and gastroesophageal reflux disease.
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Aurobindo Pharma receives FDA nod for rosuvastatin calcium tabs
Updated : 8 years, 6 months ago IST
New Delhi, July 20 (ANI): Leading Indian pharmaceutical company Aurobindo Pharma has announced receiving the final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.
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