The Generic Respiratory drugs market is growing very rapidly due to increasing incidence respiratory disorders leading to asthma, COPD and other fatal diseases. Moreover, increasing advancements related to generic medication, growing medical awareness, and strong government support would propel the demand for inhalation and nasal spray generic drugs in the coming few years. According to a Transparency Market Research the global inhalation and nasal spray generic drugs market was valued at US$26.16 bn in 2016 and is estimated to reach US$35.5 bn by 2023 at a CAGR of 5.5% from 2015 to 2023.
Therapy area of Respiratory Drug Deliverysystem Indian Generic companies are targeting to establishing a complete new setup of Respiratory Development centres, by investing 50% of their total R&D budget. As the majority of Patents are expiring in the coming years.
Ø Key Note : Approval of Inhalation Drug Products: A US Regulatory Perspective”.
Ø CMC requirements & complexities in the US Approval of Respiratory Drug products.
Ø Critical Attributes in Development of Dry Powder Inhalers”
Ø Generic Respiratory Product Development.
o Quality By Design (QBD) approach for the Development of Generic DPI formulations to meet Q1, Q2, and Q3 Requirements.
o Understanding of Device on Product performance.
o Identification of CMA & its importance on Respiratory product performance.
o Statistical Tools to establish product Equivalence.
Ø Analytical Techniques on Generic Respiratory product Analysis to meet Regulatory expectations.
o Quality By Design Tools to develop suitable analytical Methods.
o Invitro Dissolution method development for Dry powder Inhalation products.
o Analytical Method Development using Statistical Tools.
Ø State of the art simulation methods on developing inhaler.
Ø Regulatory Challenges in the development of Generic Dry powder Inhaler development.
Ø Manufacturing Challenges of Respiratory products to meet process validation guidelines.
Ø Dry powder inhaler In-vitro Device Robustness study.
Ø Micromeritic properties of Raw materials which influence on the product performance.
Ø Analytical test and technique to characterize pressurized metered dose inhaler (pMDI)”
Key Note Presentation
Dr Gur Jai Pal Singh
Head - Cipla Respiratory Center of Excellence
Dr Guirag Poochikian - EX FDA
President - Poochikian Consulting
Mr. Mark Copley -
Sales Director -
Mr. Tim Freeman
Managing Director -
Freeman Technology .
Who Should Attend
Team Members from : - R&D, New Product Development, Drug Discovery. Respiratory Product Development, Regulatory, Manufacturing Team .
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