Explore recent issues of Contract Pharma covering key industry trends.
Read the full digital version of our magazine online.
Stay informed! Subscribe to Contract Pharma for industry news and analysis.
Get the latest updates and breaking news from the pharmaceutical and biopharmaceutical industry.
Discover the newest partnerships and collaborations within the pharma sector.
Keep track of key executive moves and promotions in the pharma and biopharma industry.
Updates on the latest clinical trials and regulatory filings.
Stay informed with the latest financial reports and updates in the pharma industry.
Expert Q&A sessions addressing crucial topics in the pharmaceutical and biopharmaceutical world.
In-depth articles and features covering critical industry developments.
Access exclusive industry insights, interviews, and in-depth analysis.
Insights and analysis from industry experts on current pharma issues.
A one-on-one video interview between our editorial teams and industry leaders.
Listen to expert discussions and interviews in pharma and biopharma.
A detailed look at the leading US players in the global pharmaceutical and BioPharmaceutical industry.
Browse companies involved in pharmaceutical manufacturing and services.
Comprehensive company profiles featuring overviews, key statistics, services, and contact details.
A comprehensive glossary of terms used in the pharmaceutical and biopharmaceutical industry.
Watch in-depth videos featuring industry insights and developments.
Download in-depth eBooks covering various aspects of the pharma industry.
Access detailed whitepapers offering analysis on industry topics.
View and download brochures from companies in the pharmaceutical sector.
Explore content sponsored by industry leaders, providing valuable insights.
Stay updated with the latest press releases from pharma and biopharma companies.
Explore top companies showcasing innovative pharma solutions.
Meet the leaders driving innovation and collaboration.
Engage with sessions and panels on pharma’s key trends.
Hear from experts shaping the pharmaceutical industry.
Join online webinars discussing critical industry topics and trends.
A comprehensive calendar of key industry events around the globe.
Live coverage and updates from major pharma and biopharma shows.
Find advertising opportunities to reach your target audience with Contract Pharma.
Review the editorial standards and guidelines for content published on our site.
Understand how Contract Pharma handles your personal data.
View the terms and conditions for using the Contract Pharma website.
What are you searching for?
Gets hit with FDA warning letter
November 18, 2015
By: Tim Wright
Editor-in-Chief, Contract Pharma
Dr. Reddy’s Laboratories has purchased worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner, Alchemia Limited, for $17.5 million. Fondaparinux is a generic version of the anticoagulant drug Arixtra, which is approved in the U.S. and Europe for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and is also indicated for the prevention of DVT after major surgery, such as knee and hip replacement. Fondaparinux is recommended by the American College of Chest Physicians and received the European Society of Cardiology’s highest recommendation for use in acute coronary syndrome. Fondaparinux is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale. Alchemia has granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture Fondaparinux until at least 2022. The IP purchase comes on the heels of the receipt of a warning letter from the U.S. FDA relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. Regarding the warning letter, Dr. Reddy’s chief executive officer, G V Prasad said, “We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated time frame of 15 days. We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority.”
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !