This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.
Azelis’ customers now have access to products including the well-established Polyglykol portfolio, as well as a brand-new range of Motusflex and VitiPure excipients.
This rapid analytical technique provides additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs)
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
APIC is a contract development and manufacturing organization (CDMO) that offers a wide range of services such as synthetic route design, pilot manufacturing, investigational medical manufacturing, and commercial production, by making full use of integrated processes that combine organic synthesis technologies and biotechnologies it has cultivated over many years
Despite the price increases for raw materials and logistics, EBITDA pre rose organically by 3.2% to € 1,782 million
India exported Bulk Drugs/Drug Intermediates worth Rs. 33,320 crore in financial year 2021-22.
India exported about Rs 33,321 crore and imported Rs 35,249 crore worth APIs and Bulk drugs in 2021-22.
The approval has been accorded by IFCI Limited for manufacturing of the product "7 ACA"
Supports development and commercialization of complex oral drugs using sensitive molecules, including biologicals
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