Navigation For Mobile

Category Archives: DMF

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

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

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

Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot. Thirty…

Posted in Capabilities, Chemistry, Contract Manufacturing, DMF, FDA, Neuland Labs, Project Management, R&D, regulatory, scale-up | Comments Off on Neuland – Thirty Years of Global Pharma, Process Chemistry & APIs

API Regulatory Challenges: 5 Things You Need to Avoid

At the heart of every drug lies one or more active pharmaceutical ingredients (APIs). While the phrase “regulatory affairs” typically conjures thoughts of FDA approvals of finished-dose drugs, regulatory matters…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on API Regulatory Challenges: 5 Things You Need to Avoid

Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

We’re so excited! Neuland Labs just received a huge award – the 2013 CMO Leadership Award in the Regulatory category from Life Science Leader magazine. It’s an honor to have…

Posted in APIs, award, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Neuland Labs Receives 2013 CMO Leadership Award for Regulatory Excellence

Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

With research becoming highly-specialized, many companies are turning to CROs with particular skill-sets – especially in complex chemistry. For us at Neuland, companies tend to be looking for method development…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, genotoxic impurities | Comments Off on Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

Made in India: The Outlook for Pharma’s Manufacturing Hub

I’ve written before about the incredible speed of the Pharma industry’s growth in India, and the future outlook continues to look very bright. While the Indian pharma market is facing…

Posted in Contract Manufacturing, CRO/CMO, DMF, FDA, regulatory, scale-up | Comments Off on Made in India: The Outlook for Pharma’s Manufacturing Hub

Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…

Posted in CEP, Congtract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Planning for the Future: Evaluating a CMO’s Regulatory Capabilities