How are Indian generics companies fairing in the competitive race to serialize and ship medicines to the US?
Though the serialization deadline has passed for the Drug Supply Chain Security Act (DSCSA)in the US, companies across the globe are still in racing to serialize and ship products to the US market, as a result ofthe FDA’s decision to delay active enforcement until November 2018.
1. What does this approval mean to Idifarma?
It’s a great opportunity for growth, boosting our GMP capabilities with capsule filling in addition to immediate and modified release tablets. It is also a significant milestone in our journey so far, helping us to become a leading CDMO for small-scale niche products in solid oral forms.
1. Will this merger change any of your organizational structure and framework?
The partnership is not a merger, it is a collaboration between Recipharm and the Clinical Trial Consultants (CTC) to allow both companies to offer a complete service from formulation development to first in human studies.
What does this certification mean to you?
Achieving the highest level of certification in Atmosphere Explosive (ATEX) and International Electro Commission (IEC) Explosive (Ex) equipment,combined with recent investment in our Liverpool facility, forms an important part of our strategy to continue to develop and offer superior containment solutions worldwide.
1.Quanticate has just completed an investment initiative to upgrade its pharmacovigilance safety data base,how will the new system simplify event reporting in the EU and enhance data availability to stake holders?
1. In an environment where trial data is made available through peer reviewed articles how effective is clinical trial disclosure maturity assessment with increased risk, complexity and costs to assess global disclosure processes?