PremiumWith this Abbreviated New Drug Application (ANDA) approval for Guaifenesin and Pseudoephedrine Hydrochloride extended-release (ER) tablets, Granules now have a total of 51 ANDA approvals from US FDA.
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Hyderabad-based pharmaceutical product manufacturing company Granules India Limited on 26 August announced to have received an approval of Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride extended-release (ER) tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC).
The ANDA approval is granted by US Food & Drug Administration (US FDA). With this, Granules now have a total of 51 ANDA approvals from US FDA – 49 final approvals and 2 tentative approvals.
This approval is also equivalent to the reference listed drug product, Mucinex D extended-release tablets, 600 mg/60 mg and 1200 mg/120 mg, of RB Health (US) LLC.
The Hyderabad-based firm said that Guaifenesin and Pseudoephedrine Hydrochloride ER tablets are used to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
These tablets temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies. Also, the drug temporarily restores freer breathing through the nose and promotes nasal and/or sinus drainage, and temporarily relieves sinus congestion and pressure.
Incorporated in 1991, the Granules India Limited, distribute medical products to over 80 countries with offices across India, US and UK.