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Clinical Trials
43
11 active
Approvals
133
Total approvals
Agencies
3
Regulatory bodies
Founded
N/A
Active, not recruiting
6
13.9%
Completed
22
51.2%
Not yet recruiting
5
11.6%
Recruiting
8
18.6%
Suspended
2
4.7%
FDA
Food and Drug Administration
106
PHILIPPINES
Philippines FDA
NPRA
National Pharmaceutical Regulatory Agency
- India's first indigenous antibiotic nafithromycin faces regulatory scrutiny as the NPPA's expert committee questions whether the patent covers the approved formulation. - The Multidisciplinary Committee of Experts has directed verification from CDSCO and patent authorities to confirm alignment between the granted patent and approved drug formulation. - Wockhardt seeks five-year pricing exemption under DPCO 2013 for the groundbreaking antibiotic that targets drug-resistant Community-Acquired Bacterial Pneumonia. - The committee noted discrepancies between patent documents that don't explicitly mention "nafithromycin" and the specific CDSCO approval for 400mg tablets.
