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Category Archives: Capabilities

COPD Product Development Opportunity: Indacaterol Maleate

According to the American Lung Association, chronic obstructive pulmonary disease (COPD – which includes chronic bronchitis and emphysema) is the third-leading cause of disease-related death in the U.S. It affects…

Posted in Capabilities, COPD, CRO/CMO, DMF, drugs, FDA, generic, Indacaterol, marketing, Neuland Labs, Patent | Tagged , , , , , , | Comments Off on COPD Product Development Opportunity: Indacaterol Maleate

On SABAM, Cyanide and Safety

Levetiracetam, an epilepsy medication used for partial onset, myoclonic or tonic-clonic seizures, was first approved for medical use in the United States in 1999. As a drug, it boasts excellent…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, Effluent, EHS, generic, Neuland Labs, outsourcing, process chemistry, Process Engineering, Quality, scale-up | Tagged , , , , , , , | Comments Off on On SABAM, Cyanide and Safety

Solving the Insoluble

Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…

Posted in APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, Pharm Tech, Pharmaceutical Technology, R&D, Route Design, Route Scouting, synthesis | Tagged , , , , | Comments Off on Solving the Insoluble

A Guide to Sourcing Pharmaceutical Peptide APIs

Rise of the Peptide Era                                                                                                                                                       Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….

Posted in API synthesis, APIs, Capabilities, Chemistry, chromatography, CMC, Contract Manufacturing, CRO/CMO, Fmoc, generic, HPLC, Jitsubo, Molecular Hiving, Neuland Labs, peptide, Peptide aggregation, peptides, process chemistry, Process Engineering, synthesis, Synthesis Route, TIDES | Tagged , | Comments Off on A Guide to Sourcing Pharmaceutical Peptide APIs

Inside Neuland Technology: Bosentan Monohydrate

Pulmonary arterial hypertension (PAH) is a rare disease affecting 1-2 people per million in the U.S. and Europe. The orphan drug Bosentan, a dual endothelin receptor antagonist, is used in…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, drugs, generic, method development, Neuland Labs, Orphan drug | Tagged , , | Comments Off on Inside Neuland Technology: Bosentan Monohydrate

Case Studies from Neuland’s Process Engineering Lab

In our PE Lab, a team of 27 highly specialized engineers integrates the key attributes of QbD process understanding, process control, and continuous improvement with advanced equipment, Design of Experiments…

Posted in analytical science, API synthesis, APIs, Capabilities, Chemistry, Design of Experiment, method development, micronization, Neuland Labs, PAT, process chemistry, Process Engineering, QbD, Quality, Route Scouting, Synthesis Route | Comments Off on Case Studies from Neuland’s Process Engineering Lab

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

Speed-to-Market: Streamlining Pharma API Production

In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor. How critical? A one-day delay in reaching the market could mean the loss of $1…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, Paragraph IV, process chemistry, Process Engineering, speed-to-market, time-to-market | Comments Off on Speed-to-Market: Streamlining Pharma API Production

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…

Posted in APIs, audit, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, FDA, Neuland Labs, QA/QC, Quality, regulatory | Comments Off on 3 Success Factors for Pharma Regulatory Inspections

Medicine & Science: Keeping Up with the Pace of Change

The changes we’ve witnessed in the fields of science and medicine over the last decade or two have been truly astonishing. When we stood at the beginning of the ‘omics…

Posted in analytical science, API synthesis, Big Data, Capabilities, Chemistry, Neuland Labs, peptide, peptides | Comments Off on Medicine & Science: Keeping Up with the Pace of Change