article thumbnail

Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023). ©GlobalData.

article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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. tons of carbon dioxide equivalent (CO 2 e) for every $1m it generated – placing it above even the automotive industry, which emitted 31.4 In 2019, the pharmaceutical industry produced 48.55

article thumbnail

Jailed pharma exec fined £47m and banned from industry

pharmaphorum

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production. Many people carry the illness but do not exhibit symptoms.

article thumbnail

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Manufacturing Controls.

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., Far from it.