Market News
Global Budesonide Inhaler Market: Key Developments
- In August 2020, Lupin Limited (Lupin), a pharmaceutical company, announced that it received approval from the U.S. Food and Drug Administration (FDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir HFA (Albuterol Sulfate Inhalation Aerosol). Lupin’s generic Albuterol Sulphate MDI had been manufactured at its Indore (Unit III) facility in India. ProAir HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. (Teva) and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms
- For instance, in December 2018, Lupin, a pharmaceutical company, announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit 3) facility. The inspection at the site was conducted between June 12, 2017 and June 16, 2017. This was a pre-approval inspection for Albuterol Sulfate Inhalation product. Lupin’s Pithampur (Unit 3) facility manufactures dermatological products, dry product inhalers and metered dose inhalers. The validation will help the company to maintain highest standards in quality and compliance across the facilities.
- For instance , in February 2020, Perrigo Company plc, a pharmaceutical company and its partner, Catalent Pharma Solutions, a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA. Perrigo had launched a limited quantity of generic albuterol sulfate inhalation aerosol and, in collaboration with its development and manufacturing partner Catalent, to meet future demand in production.
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