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Iressa-API Insights, 2016

  • November 2016
  • -
  • Delve Insight
  • -
  • 35 pages



The active pharmaceutical ingredients worldwide market is in continuous development from the recent years. There is expected to be a major impact on the global API industry, with the large number of blockbuster drugs going off patent in the coming years. It is going to affect the revenue of the API market as generic drugs occupy the market.
India and China produce a large percentage of a majority of the APIs and intermediates produced in the world currently. The USFDA and EMA have strict guidelines for API manufacturing 'Process Validation: General Principles and Practices'. While countries such as Japan and Singapore are signatories to the ICH Q7 regulation, India and China follow their national GMP guidelines. The efficiency and expertise of Asian contract manufacturers have positioned them in a very strategic space in the global pharmaceutical supply chain, with a vast majority of the APIs and intermediates being sourced from markets such as India and China.

DelveInsight’s, Iressa -API Insights, 2016 Report provides marketed details and API Manufacturers details across the globe along with the location. The report gives the clear idea on the United States Drug Master File (USDMF) and Europe DMF filed by worldwide countries related to the drug. It also provides the India and China API Manufactures who are driving the current API Market. The report also highlights the patent, patent exclusivity information and competitive landscape. The research, analysis also presents the global sales forecasts data till 2015.

Data Sources

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by DelveInsight team of industry experts. Secondary sources information and data has been collected from various printable and non-printable sources like search engines, News websites, Government Websites, Trade Journals, White papers, Magazines, Trade associations, Books, Industry Portals, Industry Associations and access to available databases.
Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated drug.

Scope

- A review of the Iressa based on information derived from company and industry-specific sources
- Coverage of the Marketed data of the Iressa on the basis of MOA, target, dosage, route of administration, molecule type, strength, Chemical type and ATC Classification
- Coverage of the United States Drug Master File (US DMF), Active Substance Master File/EU DMF and API Manufactures in China & India for drug with location details.
- Patent Expiry Timeline and Exclusivity Details
- Global Forecasted Sales Figure from 2011-2015
- Qualitative and quantitative assessment of market space
Reasons to buy

- Evaluate the marketing status and exclusivity details of Iressa to exploit opportunities for generic drug development opportunities.
- Design effective counter-strategies to gain competitive advantage by identifying the key patent expiry details and exclusivity with respect to Iressa.
- API intelligence over Iressa and gaining primary intelligence over Active Ingredients manufacturers across the globe.
- Uncovering opportunities in the rapidly growing the US market
- Stay ahead of competition by understanding the changing competitive landscape
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of the drug’s performance
- Obtain sales forecast for currently marketed drug for 2011-2015

Table Of Contents

Iressa-API Insights, 2016

Illustrative Table of contents


- Drug Overview
- Global Sales Assessment
- Product Description
- Mechanism of Action
- Pharmacodynamic Properties
- Pharmacokinetic Properties
- Marketed Details for the United States
- Marketed Details for the Europe
- Patent Information
- Patent and Exclusivity Expiry Assessment United States (US)
- Patent Numbers and Expiry Details
- Patent Details
- Global API Manufacturers Assessment
- The United States Drug Master File (US DMF)
- The Europe Drug Master File (EUDMF)/Active Substance Master File (ASMF)
- The Active Pharmaceutical Ingredient (API) Manufacturers in the ASIA Region
- The Active Pharmaceutical Ingredient (API) Manufacturers by the United States Drug Master (DMF) File Status
- The Active Pharmaceutical Ingredient (API) Manufacturers by Region
- The Active Pharmaceutical Ingredient (API) Manufacturers by Location/Countries
- Generic Players
- Company Profile
- Summary
- Company Financials
- References
- Appendix
- Methodology
- About DelveInsight
- Contact Us
- Disclaimer

List of Tables

- Iressa, Market, Global Sales (in USD), 2016
- Iressa, Description
- Iressa, Marketed Details the United States (US)
- Iressa, Marketed Details the Europe (EU)
- Iressa, Patent/Exclusivity Expiry (Year), 2016
- Iressa, Patent Number Specific Patent Expiry (Year), 2016
- Iressa, Patent Details
- Iressa, the United States Drug Master File (US DMF), 2016
- Iressa, the Europe Drug Master File (EUDMF)/Active Substance Master File (ASMF), 2016
- Iressa, the API Manufacturers, China, 2016
- Iressa, the API Manufacturers, India, 2016
- Iressa, the API Manufacturers by the US DMF Status, 2016
- Iressa, the API Manufacturers by Region, 2016
- Iressa, the API Manufacturers by Location/Countries, 2016
- Iressa, Generic Players, 2016
- Company Overview, 2016
List of Figures

- Iressa, Market, Global Sales (in million USD), 2016
- Iressa, Global Sales % Change, 2016
- Iressa, Patent/Exclusivity Expiry (Year), 2016
- Iressa, Patent Number Specific Patent Expiry (Year), 2016
- Iressa, the API Manufacturers by the US DMF Status (%), 2016
- Iressa, the API Manufacturers by Region, 2016
- Iressa, the API Manufacturers by Location/Countries, 2016
- Iressa, Generic Players, 2016

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