Granules India announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC). It is bioequivalent to the reference listed drug product, Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.

Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.

Granules now have a total of 52 ANDA approvals from US FDA (50 Final approvals and 2 tentative approvals).

The Imodium Multi-Symptom Relief ®️ brand and store brands had combined U.S. sales of approximately $60million MAT for the most recent twelve months.

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Granules India announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC).

It is bioequivalent 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.

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; temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies; temporarily restores freer breathing through the nose; promotes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure.

The Mucinex®️ D brand and store brands had combined U.S. sales of approximately $71 million MAT for the most recent twelve months.

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Granules India announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC).

It is bioequivalent 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.

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; temporarily relieve nasal congestion due to common cold, hay fever, upper respiratory allergies; temporarily restores freer breathing through the nose; promotes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure.

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

The Mucinex®️ D brand and store brands had combined U.S. sales of approximately $71 million MAT for the most recent twelve months.

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Granules India announced that its wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc. has received a communication from the US FDA indicating the inspection classification as “Voluntary Action Indicated.” (VAI).

Previously, USFDA issued 6 observations under Form 483 on inspection of its facility located at Chantilly, Virginia, USA.

The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.

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