News
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Frontage Labs buys Ohi-based CRO, Concord Biosciences
Frontage Laboratories, Inc., a global contract research organization, announces the acquisition of Concord Biosciences
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Indian pharma companies secure 51 final ANDA approvals during Jan-March 2018
Indian companies have secured 51 final ANDA approvals from US FDA during the first quarter of January-March 2018, out of total 112 approvals.
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Indian pharma cos get record 300 USFDA generic drug nods in 2017
Zydus leads with 66 approvals in 2017, followed by Aurobindo (52), Glenmark (18), Lupin (17), Gland Pharma (16) and Cipla (10)
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New guidance: Good ANDA Submission Practices Guidance for Industry (January 2018)
This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA.
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2017 drug approvals report released
Report describes valuable new drug therapies approved in the U.S. Complete approved drug information also available on Formulation Diary
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