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Cosmetics and pharmaceutical

Opportunities for Reducing Sampling and Testing of Starting Materials

Source : GMP News 09/11/2016 Chapter 5 of the EC GMP Guide for the area of production was already updated last year. However, not everybody really knows that it contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Particularly sections 5.35 and  5.36 include …

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WHO issues Update of Pharmaceutical Water Guideline

The current TRS 970 of the WHO also comprises an updated version of the guideline regarding the manufacture and distribution of water for pharmaceutical use as Annex 3. This revised version contains the same chapters. The modifications are rather based on comments to the previous version which were reviewed and …

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Lilly Alzheimer’s Drug Can Save Dismal Year for Pharma

Upcoming results from late-stage data will have major impact on sector By CHARLEY GRANT Updated Nov. 22, 2016 5:06 p.m. ET After a year of drama for the health-care industry, ranging from the EpiPen pricing scandal to the collapse of Valeant Pharmaceuticals International and Theranos to the unknown future of …

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Alembic Pharma gets USFDA nod for hypertension tablets By PTI | Nov 18, 2016, 05.52 PM IST

NEW DELHI: Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for its Telmisartan and Amlodipine tablets used for treatment of hypertension. The company has received approval from the US Food and Drug Administration (USFDA) for Telmisartan and Amlodipine tablets in the strengths of of 40mg/5 mg, …

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Sun Pharma Halol site being inspected by US FDA: Sources By Vikas Dandekar, ET Bureau | Updated: Nov 18, 2016, 09.56 AM IST

MUMBAI – The US FDA has begun its inspection at Sun Pharma  Halol manufacturing facility, considered to be the most crucial for the company, according to three industry sources. Last December, the US drug regulatory agency had issued a warning letter to the same site. The action followed over 20 …

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