Baheal Pharmaceutical Co. Ltd., with its headquarters in Shanghai, celebrates as its subsidiary, Qingdao Baheal Pharmaceutical Co. Ltd., has been graced with a flawless report from the US Food and Drug Administration (FDA). The agency's recent inspection concluded with a commendable 'No Action Indicated' (NAI) classification and without a single Form 483 observation - a testament to the company's strict adherence to the Current Good Manufacturing Practice (cGMP) guidelines. This clean bill of health is not the first for Qingdao Baheal Pharmaceutical, which previously achieved a 'zero-deficiency' rating in 2016, solidifying its stellar standing with the FDA.

The FDA is universally recognized as one of the most stringent and authoritative regulatory agencies for drug quality oversight. A "zero Form 483" outcome, which aligns with cGMP standards, signals a spotless evaluation of a pharmaceutical company’s onsite quality management practices. During an extensive five-day audit of Qingdao Baheal Pharma's operations, FDA inspectors meticulously scrutinized various systems, including product quality assurance, production processes, facility and equipment maintenance, materials handling, packaging, labeling, and laboratory controls. They also thoroughly evaluated the plant’s research and development governance and production efficacy. The company was lauded for its rigorous compliance with quality management protocols and its ongoing refinement of critical processes, leading to a commendable "zero deficiency" finding.

Securing a "zero-deficiency" status for a second instance underscores the company's sustained international acclaim for superior manufacturing standards and establishes a robust base for introducing a broader range of innovative products to both domestic and global markets, thus boosting worldwide competitiveness.

Qingdao Baheal Pharmaceutical, a branch of Baheal Pharma, staunchly upholds high pharmaceutical standards and specializes in sophisticated dosage forms such as osmotic pumps, microgranule coatings, and matrix tablets. The company has a significant presence in both the Chinese and American markets. This includes their controlled-release metformin hydrochloride extended-release tablets under the brand name Naidia®, which debuted in the United States in 2019. Naidia® was recognized for its exceptional clinical benefits and incorporated into the Chinese National Medical Insurance in 2023. Furthermore, other noteworthy products like the celecoxib capsules branded as Naichi® and the Naite® nifedipine controlled-release tablets have been handpicked for national procurement within China.

Beyond crafting advanced controlled-release drugs, Baheal Pharma, the parent entity of Qingdao Baheal and a burgeoning powerhouse in China's pharmaceutical landscape, has ventured into contemporary R&D and production of traditional Chinese medicine (TCM). They have set up an extensive industrial process for modern TCM that spans R&D, cultivation and handling of herbs, extraction, and final product formulation. Their proprietary TCM innovation, the Fuzhenghuayu series, has demonstrated through clinical trials its capacity to reverse liver fibrosis. This series has the distinction of being the first Chinese TCM specifically targeting liver ailments to reach Phase II clinical trials in the United States.

Bolstered by national policies that spur innovation and hasten the release of new drugs, Baheal Pharma is actively aligning with prominent national research bodies and academic institutions to quicken the tempo of its inventive initiatives. The company is strategically positioned to expand its portfolio with an increased array of sophisticated formulations and exclusive, modern takes on traditional Chinese medicine. With a firm adherence to the stringent Good Manufacturing Practice (GMP) guidelines, Baheal Pharma is dedicated to delivering patient-centric solutions through its innovative products and proprietary intellectual property, all aimed at significantly improving healthcare outcomes and enriching the wellbeing of communities.