Source:
https://www.dsij.in/DSIJArticleDetail/ArtMID/10163/ArticleID/11520/Granules-India-gets-USFDA-nod-for-Guaifenesin-ER-tablets
https://www.dsij.in/DSIJArticleDetail/ArtMID/10163/ArticleID/11520/Granules-India-gets-USFDA-nod-for-Guaifenesin-ER-tablets
Granules India informed the bourses on Thursday that the company received
tentative approval for its Abbreviated New Drug Application (ANDA) from US Food
and Drug Administration (USFDA) for Guaifenesin Extended-release tablets, 600
mg and 1,200 mg.
The approved drug is the generic equivalent of Mucinex Extended-release
tablets, 600 mg and 1,200 mg of RB Health (US), and is used to help loosen
phlegm and thin bronchial secretions to rid the bronchial passageways.
Commenting on the approval, Priyanka Chigurupati, Executive Director of
Granules Pharmaceuticals stated that the drug was a nice addition to the
company's growing Over the Counter (OTC) product portfolio in US market and it
looked forward to bring this product to market upon patent expiry in April
2020.
Granules India is a
pharmaceutical company, having a presence across the pharmaceutical
manufacturing value chain, including Active Pharmaceutical Ingredients (APIs),
Pharmaceutical Formulation Intermediaries (PFIs) and Finished Dosages (FDs).
The company now has a total of 23 ANDA approvals from USFDA, including 21 Final
approvals and 2 tentative approvals.
