Generic Drugs

Best practices help mitigate generic drug shortages.

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Advanced manufacturing technologies are available, but challenges need to be addressed.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

FDA and the US Congress support innovation and access to cheaper medicines.

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

A quick look at the history of OTC dosage form development shows the importance of patient-centered innovation.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Perrigo will be producing a limited amount of the generic inhaler medication but will accelerate production to meet future demands in collaboration with Catalent.

A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues

Neuraxpharm Group has announced it is launching its first products in the United Kingdom.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.

A CPhI Middle East & Africa (MEA) expert has forecasted a boom in manufacturing in the region and has expectations that within five years some of the industry will be acting as contract manufacturers for the European market.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Cambrex’s expanded quality control laboratory supports generic API development.