Proceeds from the proposed issue will be utilized to part finance Balaxi’s planned EU GMP-compliant manufacturing facility for Oral Solid Dosages and Liquid Injectables at TSIIC Pharma Formulations SEZ
The capital expansion program commenced in June 2022 and is expected to complete in 2024
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The unit has filed 2 Derma products and 1 MDI product.
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
With this, the company can start selling Ibuprofen in the European markets.
The expansion at CDMO facility in South Haven, will bring a new 4,000-gallon multi-use reactor train consisting of glass lined and stainless-steel materials of construction
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
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