Cadila inks pact with Italian firm to launch generic product in US thehindubusinessline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehindubusinessline.com Daily Mail and Mail on Sunday newspapers.
Gland Pharma received approval from the United States Food and Drug Administration (US FDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion.
Generic Foscarnet Sodium Injection is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Foscavir Injection, 24 mg/mL, of Clinigen Healthcare.
With this approval, Gland Pharma secured the first generic offering status in Single-Dose Bag for Infusion. Gland Pharma is backward integrated with in-house API source for this product. Gland Pharma intends to supply this product globally and recently launched the product in the Canadian market. Global markets size is estimated to be $50 million.
Gland Pharma received approval for generic Foscarnet Sodium Injection, Single-Dose Bag for Infusion equitybulls.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from equitybulls.com Daily Mail and Mail on Sunday newspapers.
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WESTON, Fla., Feb. 2, 2021 /PRNewswire/ -
Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.
Carton 100mg/mL (CNW Group/Apotex Corp.)