API Quality

22/05/2024

Reworking.
Is it acceptable for API and it's intermediate?

Chemical or physical?
What regulatory expect?

22/05/2024

Requirement of finding right supplier for key starting materials, specific guideline?
1) What are the steps, we should ensure during initial selection and in routine monitoring?
2) When it is time to stop use of the supply from vendor?

25/12/2023

https://www.livemint.com/economy/fdas-unannounced-inspection-halt-in-india-raises-concerns-house-republicans-threaten-subpoena-11702612108671.html

FDA is threatened with a subpoena if it fails to produce requested documents by Jan. 5, as House Republicans seek information on FDA discussions with Defense Department and the disbanding of unannounced inspection pilot in India.

06/04/2023

API QBD

26/12/2022

https://www.europeanpharmaceuticalreview.com/article/174607/economics-and-risks-of-fdas-quality-management-maturity-rating-programme/

The introduction of pharmaceutical manufacturing quality ratings by the FDA under its Quality Management Maturity (QMM) programme has the potential to reduce drug shortages and improve pharmaceutical company financial performance. Here, Dr Clifford Rossi of the University of Maryland explains.

26/12/2022

https://www.europeanpharmaceuticalreview.com/news/175307/hpapi-contract-manufacturing-to-value-14-6-billion-by-2030/

Rising demand for cancer drugs, combined with high in-house manufacturing costs is driving growth in the high-potency API outsourcing market.

06/11/2022

Great news for API professionals.. New huge API Park coming soon in gujarat.

28/07/2022

https://cen.acs.org/business/finance/CENs-Global-Top-50-2022/100/i26?utm_source=NonMember&utm_medium=Newsletter&utm_campaign=CEN

The world’s chemical industry has recovered from the COVID-19 pandemic and is now riding the wave of higher prices

04/07/2022

https://m.economictimes.com/industry/healthcare/biotech/pharmaceuticals/pharma-companies-are-now-busy-adding-capacities-and-seeing-a-surge-in-demand-for-non-covid-drugs/articleshow/91566425.cms

Indian drug manufacturers launch 300-350 new brands (mostly repurposed or combinations of two earlier drugs) every year. This had slowed down in the initial months of Covid-19 as most companies were trying to assess the situation. But with Covid cases falling, new launches are almost back to preCovi...

23/06/2022

It's shameful for Indian Pharma feternity. Patient safety should not be neglected for bunch of money. It is expected authorities and organisations should follow ethical and right practices.

https://www.moneycontrol.com/news/business/cbi-arrests-jt-drugs-controller-in-bribery-case-to-clear-biocon-biologics-injection-8716561.html

Biocon Biologics is a subsidiary of the Kiran Mazumdar Shaw-led Biocon. The company has denied allegations.

14/06/2022

https://www.europeanpharmaceuticalreview.com/news/157247/global-api-market-to-value-300-billion-by-2030/

Growth of the aging population and rising investment in biologic drugs to promote the expansion of the global active pharmaceutical ingredient (API) market.

09/06/2022