Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze
36.4% of patients with diabetic neuropathic pain in 2021 were completely treatment refractory and would benefit from new treatment options.
This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled study
Joint Drugs Controller (India) Dr PBN Prasad shared his views about working during harsh COVID-19 pandemic days
Total investment envisaged in this project stands at up to Rs 70 crore
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The company had responded to the agency and carried out the required corrective actions.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The observation is procedural in nature and the company will address the observation within stipulated timelines.
This will dramatically improve timely intervention with the right experts thus ensuring significant improvement in patient’s condition management and health outcome
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