Panacea Biotec Pharma Formulation Facility Gets FDA Approval

Panacea Biotec’s pharmaceutical formulation facility, spanning over 10,925m2, has blocks for oral solids, semi-solids and liquid oral dosage forms. The oral dosage form block has capability to manufacture tablets, hard gelatin capsules and soft gelatin capsules with a line for production of immuno-suppressants.

Additionally, the pharmaceutical formulation facility’s equipment has annual production capacity of 900m tablets, 120m capacity of hard and soft gelatin capsules each, 12m tubes of semi-solids and 1.2m liters of liquid orals.

Panacea Biotec claimed that the pharmaceutical formulation facility is already cGMP certified by ANVISA-Brazil, Government of Upper Bavaria, Germany, TGA-Australia and regulatory agencies of other ROW markets like Jordan, Syria, Ukraine, Yemen etc.

Sumit Jain, director of operations and projects at Panacea Biotec, said: “Recent approvals from regulatory agencies of Germany, Australia and now US is in line with the plan of the company to expand formulation business to ICH markets. We expect to launch products in US very soon through our distribution partner.”