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Category Archives: generic

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 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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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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Neuland Patent Spotlight: Paliperidone Palmitate & Antipsychotics

The use of anti-psychotic drugs to treat conditions such as schizophrenia and bipolar disorder is on the rise and estimated to reach $18.5 billion by 2022. It is a market…

Posted in Chemistry, DMF, generic, IP, Neuland Labs, Patent, process chemistry | Comments Off on Neuland Patent Spotlight: Paliperidone Palmitate & Antipsychotics

Big Pharma Keeps Getting Bigger…by Shrinking?

An article at Pharma Manufacturing (Shrinking Big Pharma) pointed to the recent movement among Big Pharma towards smaller production floors. It comes as no surprise. With the rise of target-based…

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Generic Drugs: Despite Dominance, Consumer Perception Issues Linger

Generics: U.S. Drug Industry Dominance The last time you filled a prescription, was it a generic or a brand name drug? An astonishing 89% of all drug prescriptions in the…

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