The United States Food and Drug Administration (US FDA) has sent Atul Bioscience Ltd (ABL), a 100% subsidiary of Atul Ltd, an Establishment Inspection Report (EIR) for its production plant located in Ambernath, Maharashtra. Following the facility’s most recent inspection, which took place from May 6–10, 2024, and resulted in zero FDA 483 findings, the EIR was released. The company’s activities include contract manufacturing, intermediate production, and the production and sale of active pharmaceutical ingredients (APIs).
“This is a significant milestone for our Company and a testament to our commitment to maintaining quality, safety, and compliance in our manufacturing processes,” ABL’s managing director, Dr. Prabhakar Chebiyyam, remarked in response to this accomplishment. The accomplishment of this examination, he continued, “reflects the dedication and hard work of our entire team.” It fortifies our commitment to continuously provide pharmaceutical goods of the highest caliber and to further enhance our procedures in order to satisfy the constantly changing demands of the world pharmaceutical market.
Concerning ABL
In addition to contract manufacturing, ABL is involved in the production and marketing of APIs and their intermediates for various therapeutic areas, including antiasthmatic, antidepressant, antidiabetic, antifungal, anti-infective, anti-inflammatory, antineoplastic, antiretroviral, and cardiovascular. Its factories are situated in Ambernath, Maharashtra, and Atul, Gujarat.
For further details, kindly visit www.atulbio.co.in.