Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
With this expansion, the Grand Island site provides redundant capacity to support global supply of media and further extends the site’s capabilities to produce the high-quality technology and materials needed for the development and commercial manufacturing of vaccines and biologic therapies
The two generic drugs have been launched under the brand names Jankey & Sitenali.
The round was closed with an investment from the European Circular Bioeconomy Fund (ECBF) and the two existing investors, Sofinnova Partners and Novo Seeds
The combined company will be able to better serve both our global and regional customers with local production
The acquisition continues the growth and expansion course of the ALPLApharma business division established in 2019
The research here will mainly concentrate on the manufacturing process of biopharmaceuticals, especially in the area of advanced medicines, as well as the fermentation-based manufacture of ingredients for foods and food supplements
The acquisition is subject to customary closing conditions and necessary regulatory approvals. The financial terms of the transaction are confidential
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