The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product
Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space
The biosimilar Ustekinumab has been developed and manufactured by the company
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations
Subscribe To Our Newsletter & Stay Updated
