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Category Archives: CRO/CMO

Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

Posted in APIs, blockbuster, CDMO, Chemistry, Contract Manufacturing, COVID19, CRO/CMO, outsourcing, supply chain | Tagged , , , , | Comments Off on Pharma Trends for 2021

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

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

2020: Looking Forward & Listening to Customers to Address Pharma Needs

2020 is here and we’re starting the New Year off right. We’re listening closer to – and learning more from – you, our customers. Last November’s CPhI Frankfurt provided valuable…

Posted in APIs, Contract Manufacturing, CPhI, CRO/CMO, generic, Neuland Labs, peptide, peptides | Tagged , , , , | Comments Off on 2020: Looking Forward & Listening to Customers to Address Pharma Needs

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…

Posted in Contract Manufacturing, CRO/CMO, FDA, Neuland Labs, QA/QC, Quality | Tagged , , , | Comments Off on Fostering a Quality Culture to Support Drug Manufacturing

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

The Unblockbuster – Speeding Cures with Specialty Drugs

For years, industry soothsayers have suggested the imminent demise of blockbuster drugs was upon us (here’s one from 2009 – Goodbye blockbuster medicines; hello new pharmaceutical business models). But two…

Posted in blockbuster, CRO/CMO, drugs, generic, Orphan drug | Tagged , , , | Comments Off on The Unblockbuster – Speeding Cures with Specialty Drugs

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