Title: Good News! Breathgreen's Olodaterol Hydrochloride API Passes U.S. FDA Completeness Assessment
Recently, Olodaterol Hydrochloride, an API product of our company, Breathgreen Pharmaceutical Co., Ltd., has successfully passed the Completeness Assessment conducted by the U.S. Food and Drug Administration (FDA). This achievement not only marks another significant milestone for Breathgreen in deeply engaging in the field of APIs for inhalation preparations and building a full-series respiratory API supply system, but also provides direct support for pharmaceutical customers' Abbreviated New Drug Application (ANDA) submissions, facilitating their accelerated entry into the U.S. market.
About Olodaterol HydrochlorideOlodaterol
Hydrochloride was originally developed by Boehringer Ingelheim and officially approved for marketing by the U.S. FDA on July 31, 2014. As a long-acting beta₂-adrenergic receptor agonist (LABA), it exhibits high selectivity for beta₂-adrenergic receptors. Upon inhalation, it rapidly induces bronchodilation and is primarily indicated for the long-term maintenance treatment of airway obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, and other related conditions.
Steady Progress in Global Registration
The successful completion of the U.S. FDA Completeness Assessment represents a crucial step in the global registration layout of Olodaterol Hydrochloride. Prior to this, the product obtained the "Approval Notice for Chemical API Marketing Application" (Registration No.: Y20230001076) issued by the National Medical Products Administration (NMPA) in August 2025, officially launching its domestic marketing. Currently, the application for the Certificate of Suitability to the European Pharmacopoeia (CEP) for this product has been submitted and is under review, with the global registration process steadily accelerating.
Win-Win Cooperation for a New Journey
Breathgreen Pharmaceutical Co., Ltd., has long been deeply engaged in the field of APIs for inhalation preparations, offering a full range of inhalation API supply and powder customization services. Adhering to "international quality" as its core strategy, the company upholds the bottom lines of compliance and quality, and is committed to providing cost-effective API products and professional services to global customers. We sincerely invite all pharmaceutical customers to consult and cooperate with us to jointly promote the global development and marketing of high-quality inhalation preparations and explore a new future in the respiratory health industry.
