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Author Archives: Saharsh Davuluri

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 , | Leave a comment

Deuterated Drugs Reach Two-Year Anniversary

We’ve reached the two year anniversary of the first FDA approval of a deuterated molecule (April 2017, Teva’s Astedo – a deuterated version of tetrabenazine for the treatment of Huntington’s…

Posted in APIs, Chemistry, CMC, Contract Manufacturing, deuterated molecule, deuteration, deuterium exchange, method development, Neuland Labs, process chemistry | Tagged , , , | Comments Off on Deuterated Drugs Reach Two-Year Anniversary

Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

The first in the class of drugs known as selective relaxant binding agents (SRBA), Sugammadex sodium is used to reverse anesthesia. Via 1:1 binding of rocuronium or vecuronium, it rapidly…

Posted in Chemistry, CMC, Contract Manufacturing, generic, Impurity profile, process chemistry, Process Engineering, Route Design, Synthesis Route | Tagged , | Comments Off on Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

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…

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Pharma Tech Transfer Gets Collaborative

Drug manufacturing technology transfer is one of the most complicated and demanding processes in the drug company-contract development organization relationship. There is one overriding deliverable that must go right –…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, process chemistry, Process Engineering, R&D, scale-up, technology transfer | Tagged , , | Comments Off on Pharma Tech Transfer Gets Collaborative

TIDES TV: The Past, Present & Future of Peptides

Dr. Mike Anwer – Neuland’s President of Peptide Synthesis – recently sat down with Andy Busrt of TIDES TV to discuss the peptide drug market. Peptides – From Insulin to…

Posted in APIs, AsiaTIDES, Contract Manufacturing, Neuland Labs, peptide, peptides, TIDES | Tagged , , | Comments Off on TIDES TV: The Past, Present & Future of Peptides

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

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

Drug API & Peptide Trends: 2019

With the global population continuing to both increase and age, pharma industry growth is likely to continue. While facing pricing hurdles in well-established mature markets, the emerging drug markets (China,…

Posted in API synthesis, APIs, CDMO, Contract Manufacturing, CRO/CMO, generic, Neuland Labs, peptide, peptides, process chemistry, Process Engineering, QA/QC, QbD, regulatory, Route Design, Route Scouting | Comments Off on Drug API & Peptide Trends: 2019

Pharma API Supply Chains: Mitigating Risk

The risks to pharmaceutical supply chains grow in parallel with the industry itself. As drug markets have become increasingly complex and global in nature, so – too – have drug…

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