Favorable Outlook for Generic APIs - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Favorable Outlook for Generic APIs
A spate of drugs are scheduled to come off patent, offering vast potential and competition.

Pharmaceutical Technology

The SOCMA-EFCG statement specified that the level of foreign inspections has not kept pace with changing API supply patterns. In 2005, the associations specified that FDA conducted 163 inspections of foreign API manufacturers, of which 14 (9%) were in China and 23 (14%) were in India, which was not proportional to the quantity of APIs being imported (3).

A similar concern exists in the EU, where the European Directorate for the Quality of Medicines inspected about 80 API manufacturing sites during a seven-year period, with roughly half of those inspections in China and India (3).


1. P. Van Arnum, "The Changing Fortunes of APIs," Pharm. Technol. 31 (1), 52–58, 2007.

2. R. Silver, "A Wall Street Perspective on Generics," Generic Pharmaceutical Association Annual Meeting, Phoenix, AZ, Mar. 1–3, 2007.

3. "Uneven Enforcement Leads to Sub-par Drugs and National Security Risk," European Fine Chemicals Group (EFCG, Brussels, Belgium) and the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC), Aug. 22, 2006.

4. G. Villax and C.Oldenhof, "Global API Sourcing: What is Next for Suppliers to the European Union," Pharm. Technol. Sourcing and Management 2 (7), e10–e19 (2006).

5 P. Van Arnum, "EFCG Looks to Add Muscle to New EU Directive on APIs," Pharm. Technol. Sourcing and Management 2 (3), e14–e20 (2007).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here