article thumbnail

STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems

STAT News

federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. After a decade of manufacturing problems, a U.S. However, the U.S. Continue to STAT+ to read the full story…

article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

article thumbnail

Pharma’s climate change vulnerability and opportunity

pharmaphorum

Water-borne illnesses are also likely to become more common, as increased rain and storm surges contribute to flooding and contaminated run off. To continue operations sustainably – and be in a position to rise to such public health opportunities – companies need to develop a “deep understanding of climate risk”. Vulnerability .

article thumbnail

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

So, without further ado, a moment of praise amongst the criticism: Despite its inability to please everyone, the FDA protects, lengthens, and improves the quality of hundreds of millions of lives through its work regulating the development, creation and distribution of medical products. The medications that we obtain in the U.S.,

article thumbnail

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Between 2012-2018, inspectors found “deficiencies” in 64% and 59% of foreign and domestic establishments, respectively.

Drugs 71
article thumbnail

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 previously $59.4