Posts by Lisa Tilley Hinkle

Lisa serves as the Managing Editor at PharmSource. She holds a BS degree in journalism from Radford University, and has over 20 years of experience in editing, writing and managing newsletters and other print media, including B2B publications related to industries including science, pharmaceuticals, biologics and medical devices.

Sizeable South African Market Attracts, Challenges Pharma Industry Investment

South Africa’s pharmaceutical market, the largest and most developed in Sub-Saharan Africa, is expanding at a good clip, making it attractive to drug makers seeking a foothold in the broader African region. Those opportunities are challenged by such factors as intellectual property issues, regulatory inconsistency, remoteness from other global markets and relatively low per capital […]

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Growing Mexico Is Home to Solid CMO Population

Proximity to the US, a strong regulatory scheme, affordability and decades-long relationships forged with the help of the North American Free Trade Agreement (NAFTA) are among the factors that may make Mexico an attractive location for contract manufacturing services, particularly for products sold in the US or Latin American markets. The country is also fairly […]

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No Guidance Yet, But FDA Begins Clarifying Quality Metrics Program

The FDA will soon expect pharmaceutical manufacturers to collect certain data related to their quality systems under its burgeoning quality metrics program and submit those to the FDA for review. CMOs will be required to collect these data for their own facilities; whether they will need to provide those data to their clients or directly […]

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Aenova Expands Injectables Capacity, Consolidates Network

Aenova has made a significant investment to expand its injectables capacity while consolidating the rest of its manufacturing network. The company announced the completion of a €6 million ($6.6 million) investment at its injectables facility in Wolfratshausen, Germany. The project provided for the complete separation of cytotoxic and non-cytotoxic products at the facility; it can […]

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Recent Deals Highlight Threat to CMO Supply Base

Uncertainty is creeping into the supply of contract injectables manufacturing capacity as bio/pharmaceutical companies continue to buy up CMOs. With biopharmaceuticals approaching 50% of the expanding new product pipeline, biopharma companies may be facing challenges in arranging for launch capacity. Two deals have been announced in the past month that continue the trend of CMOs […]

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PiSA Targeting Contract Manufacturing Opportunities

PiSA Farmaceutica, which claims to be Mexico’s largest pharmaceutical company, is expanding its presence in contract manufacturing. The company has seven facilities manufacturing pharmaceuticals, including injectables and oral dose forms, as well plants manufacturing medical devices and wound dressings. Pharmaceutical capabilities include hormone, cephalosporin, cytotoxic and biopharmaceutical products. “We export contract-manufactured devices; we started in […]

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Quality Systems, Data Integrity among Most Frequent Problems Cited by MHRA

Pharmaceutical manufacturers around the world, including CMOs, subject to inspection by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) can expect to see a more intense focus on quality systems and data integrity. Problems related to quality systems are the most prevalent observations during inspections of pharmaceutical manufacturers, including CMOs, in the UK, according […]

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