PHOENIXVILLE, PA — Facet Life Sciences, a firm specializing in regulatory guidance for life science companies, has announced ...

PLD also has added gummy manufacturing capabilities, including a small line for R&D and scale-up, as well as four additional commercial lines in a dedicated facility in Copiague, NY, with an ...

The drugs we use as prescribed by doctors represent the product approved by the FDA for a specified medical use under its NDA or BLA. Let’s take a look at some of the technical definitions ...

This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic ...

For example, the registration fee as part of the Generic Drug User Fee (GDUFA) for an Abbreviated New Drug Application (ANDA) in the US is around $3,21,920 (it varies in cases of formulations and ...

has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg," company said in its press ...

Mumbai: Global pharma major Lupin Limited has announced that the company has launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, following the approval of its Abbreviated New ...

This version targets partial-onset seizures, a prevalent condition, extending much-needed affordability. Lupin's market entry follows the approval of its abbreviated new drug application (ANDA) from ...

Drug firm Lupin Limited on Wednesday (May 7) said it has launched eslicarbazepine acetate tablets in the US after securing approval from the US Food and Drug Administration (FDA) for its abbreviated ...

Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and ...