New Drug Approvals For Lupin
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Lupin Receives Tentative Nod For Anti-Seizure Drug; Stock Edges Higher
"The company (Lupin) has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets," Lupin said
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Lupin Gains Nearly 1% As Subsidiary Gets New Drug Approval
The USFDA approved Lupin's US-based arm's supplemental new drug application (sNDA) to expand the use of Solosec for treating trichomoniasis in adults, Lupin said
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New Drug For Treating Schizophrenia Approved
Drug firm Lupin today said it has received US health regulator's approval to market generic version of Seroquel XR tablets, used in the treatment of schizophrenia, in the American market.
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Lupin Gets USFDA Nod For Generic Pain Relieving Drug
Currently, Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA.
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Indian Pharma's Focus On Acquisitions To Limit Deleveraging: Fitch
New Delhi: In line with global trends in thepharmaceuticals sector, the focus of domestic drug firms on acquisitionsto consolidate their position will limit deleveraging for thetime being, rating agency Fitch has said. "The ongoing focus of the top Indian pharma companies' onselective acquisitions to limit deleveraging over the shortterm," Fitch...
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Lupin Gets Final Nod From USFDA For Birth Control Pill
Lupin has received final approval from the US health regulator for marketing Norgestimate and Ethinyl Estradiol tablets in the US market.
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Lupin Expects US FDA Approvals From Goa Factory In Two Months
Lupin has about a dozen new products ready for export to the U.S. from the Goa facility, each worth about $20 million to $30 million in revenue, that have been delayed, Managing Director Nilesh Gupta said.
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Rosier Year-End Seen for Indian Pharma Thanks to Faster US Approvals
India's pharmaceutical industry is expected to see sales and profit growth accelerate in the second half of the year, thanks to a pickup in the pace of US approvals for new drugs, offsetting any downturn in volatile emerging markets.
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Sun Pharma, Lupin Surge on New Drug Approval
Analysts say the market for Xenazine is around $319 million annually and Sun Pharma can expect sales of $6-7 million per month from this drug. Sun Pharma expects to launch this product in last quarter of 2015.
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Lupin gets US regulator's nod for additional strengths of cholesterol drug
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
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Slow drug test approvals put industry at risk
Slower government approval for testing new medicines is threatening India's aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drug firms to shift operations elsewhere, adding to their costs.
_636307919644516272.jpg?downsize=260:195 "New Drug For Treating Schizophrenia Approved")
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Lupin Receives Tentative Nod For Anti-Seizure Drug; Stock Edges Higher
"The company (Lupin) has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets," Lupin said
-
Lupin Gains Nearly 1% As Subsidiary Gets New Drug Approval
The USFDA approved Lupin's US-based arm's supplemental new drug application (sNDA) to expand the use of Solosec for treating trichomoniasis in adults, Lupin said
-
New Drug For Treating Schizophrenia Approved
Drug firm Lupin today said it has received US health regulator's approval to market generic version of Seroquel XR tablets, used in the treatment of schizophrenia, in the American market.
-
Lupin Gets USFDA Nod For Generic Pain Relieving Drug
Currently, Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA.
-
Indian Pharma's Focus On Acquisitions To Limit Deleveraging: Fitch
New Delhi: In line with global trends in thepharmaceuticals sector, the focus of domestic drug firms on acquisitionsto consolidate their position will limit deleveraging for thetime being, rating agency Fitch has said. "The ongoing focus of the top Indian pharma companies' onselective acquisitions to limit deleveraging over the shortterm," Fitch...
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Lupin Gets Final Nod From USFDA For Birth Control Pill
Lupin has received final approval from the US health regulator for marketing Norgestimate and Ethinyl Estradiol tablets in the US market.
-
Lupin Expects US FDA Approvals From Goa Factory In Two Months
Lupin has about a dozen new products ready for export to the U.S. from the Goa facility, each worth about $20 million to $30 million in revenue, that have been delayed, Managing Director Nilesh Gupta said.
-
Rosier Year-End Seen for Indian Pharma Thanks to Faster US Approvals
India's pharmaceutical industry is expected to see sales and profit growth accelerate in the second half of the year, thanks to a pickup in the pace of US approvals for new drugs, offsetting any downturn in volatile emerging markets.
-
Sun Pharma, Lupin Surge on New Drug Approval
Analysts say the market for Xenazine is around $319 million annually and Sun Pharma can expect sales of $6-7 million per month from this drug. Sun Pharma expects to launch this product in last quarter of 2015.
-
Lupin gets US regulator's nod for additional strengths of cholesterol drug
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
-
Slow drug test approvals put industry at risk
Slower government approval for testing new medicines is threatening India's aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drug firms to shift operations elsewhere, adding to their costs.
