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Category Archives: FDA

Fostering a Quality Culture to Support Drug Manufacturing

As an API manufacturer, when it comes to product safety in the pharmaceutical space the stakes couldn’t be higher. We’ve written a few posts recently on modifications to regulatory inspection…

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What the Revised FDA CDER SSM Really Means

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

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Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

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How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

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Inside Propofol: Tackling the Challenges of Lipophilicity

Some drugs and APIs are more challenging to produce than others – and Propofol is an excellent example. If the name Propofol rings a bell, it’s likely because the drug…

Posted in APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, DMF, FDA, generic, Neuland Labs | Tagged , , | Comments Off on Inside Propofol: Tackling the Challenges of Lipophilicity

Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

Drug product volumes have been shrinking as increasingly niche products emerge to treat various conditions. Coupled with the rise of pharmaceutical manufacturing outsourcing, this has led to a reconsideration of…

Posted in APIs, Chemistry, Contract Manufacturing, cytotoxic, drugs, FDA, Neuland Labs, oncology, regulatory, Schedule M | Tagged , , , , | Comments Off on Non-Cytotoxic Drug Compounds & India’s GMP Schedule M

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

Neuland & Regulatory Excellence

With more than 650 regulatory filings to date, Neuland is committed to total compliance and regulatory excellence. In fact, we consider it our core competency: the application of strong process…

Posted in APIs, audit, award, Capabilities, CDMO, Contract Manufacturing, FDA, Neuland Labs, QA/QC, Quality, Quality Agreement, regulatory, Uncategorized | Comments Off on Neuland & Regulatory Excellence

3 Success Factors for Pharma Regulatory Inspections

Current Good Manufacturing Practices (cGMPs) are an essential aspect of compliance, and attention on them by regulators is growing. In today’s global pharma industry, it’s common to have multiple investigators…

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Defining the Relationship Between the Pharma Industry & Regulatory Agencies

I read an article at PharmTech at the tail end of 2016 that I thought was quite interesting, and it reflects Neuland’s position on regulatory agencies & issues. The article…

Posted in Contract Manufacturing, CRO/CMO, drugs, FDA, Neuland Labs, Pharm Tech, Pharmaceutical Technology, Quality, regulatory | Comments Off on Defining the Relationship Between the Pharma Industry & Regulatory Agencies