At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
With more than 35 years of experience, Best Formulations is the largest manufacturer of plant-based softgels in the United States, with newly expanded capabilities for nutritional gummies and personal care
The patent also covers the efficacy of the herbal composition in the management of metabolic syndrome disorders
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting
Plans to double its manufacturing footprint to bolster the growth
This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform
The combined company will be able to better serve both our global and regional customers with local production
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