Ranbaxy to pay heavily for future US violations

Ranbaxy Laboratories Ltd.- (Amalgamation) | Pharmaceuticals & Drugs | Healthcare | BSE: 500359 | NSE: RANBAXY

27 Jan 2012 Evaluate

Ranbaxy Laboratories will have to perpetually be on its toes, as the ‘consent decree’ it signed with the US Food and Drug Administration (USFDA) last month stipulates financial penalties that could run into several millions of dollars for any future flaws. The consent decree filed by the US Department of Justice, on behalf of USFDA, with the district court at Maryland, contains a lengthy list of “liquidated damages provisions” agreed by Ranbaxy. The decree, meant to resolve all pending regulatory issues with USFDA, stipulates that all Ranbaxy facilities that manufacture medicines for the US market can be covered under this “decree” in case of future violations. The existing current good manufacturing practice (CGMP) and data integrity issues are linked to Ranbaxy’s Paonta Sahib, Batamandi and Dewas, facilities, as well as CGMP issues at Ranbaxy Inc’s wholly owned subsidiary, Ohm Laboratories’ facility in Gloversville, US.

Ranbaxy has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications. The firm has further agreed to relinquish any 180-day marketing exclusivity it may have for several additional generic drug applications if it failed to meet certain decree requirements by specified dates. The company has not disclosed the details of its three potential candidates, whose exclusivity depends on the speed with which Ranbaxy meet the decree requirements. The consent decree signed on December 20 contains liquidated damages provisions to cover many potential violations of the law and the decree. Thus, Ranbaxy has agreed to pay $15,000 in liquidated damages for each day of violation of the law or the decree at the facilities covered by the decree and an additional sum of $15,000 for each overall violation of the law and the decree. Announcing the signing of the decree, Ranbaxy had separately disclosed its decision to make a provision of $500 million in connection with the investigation by the US Department of Justice, towards settlement of all potential civil and criminal liability.

Under this agreement, once Ranbaxy achieved compliance with the data integrity requirements, a third-party expert must conduct audits of the facilities to confirm that compliance is being maintained. The consent decree requires that Ranbaxy comply with detailed data integrity provisions before the FDA will resume reviewing drug applications containing data or other information from the Paonta Sahib, Batamandi, and Dewas facilities. In addition, the consent decree prevents Ranbaxy from manufacturing drugs for introduction to the US market and for the President’s Emergency Plan for AIDS Relief Program at the Paonta Sahib, Batamandi, Dewas, and Gloversville facilities until drugs can be manufactured at such facilities in compliance with US manufacturing quality standards. Ranbaxy’s Paonta Sahib, Batamandi, and Dewas, India facilities have been on FDA import alert since 2008 and Ranbaxy had closed its Gloversville facility.

Ranbaxy Labs. Share Price

Not Listed

View Price Chart

Peers

Company Name	CMP
Sun Pharma. Inds.	1939.75
Dr. Reddys Labs.	1213.20
Cipla	1417.85
Lupin	2444.65
Zydus Lifesciences	1142.30
View more..

Ranbaxy to pay heavily for future US violations

Create stable, long-term investment portfolio with strong, consistent stocks.

About MoneyWorks4Me

Our Vision

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

Name of the IA registered with SEBI:	The Alchemists Ark Pvt. Ltd.
Logo:
Trade/Brand Name of IA:	MoneyWorks4Me Investment Advisers
Brand Logo:
SEBI Registration Number:	INA000013323 Validity – May 16, 2019 – Perpetual
Registration:	Non-Individual
BSE Enlistment No:	1187
Address:	B-101, Signet Corner Building, Balewadi Phata, Baner, Pune, Maharashtra 411045
Compliance officer Details:	Name: Shrikant Jagtap Email: shrikant.jagtap@moneyworks4me.com Telephone: +919860359463 Address: Same as IA
Grievance Officer Details:	Name: Mukta Vaze Email: mukta.vaze@moneyworks4me.com Telephone: +91 98609 19463 Address: Same as IA
Principal Officer Details:	Name: Atharva Bhide Email: atharva.bhide@moneyworks4me.com Telephone: +91 91758 99463 Address: Same as IA
Standard Warning:	Investment in securities market are subject to market risks. Read all the related documents carefully before investing.
Disclaimer:	Registration granted by SEBI, enlistment with exchange and certification from NISM in no way guarantee performance of the intermediary or provide any assurance of returns to investors.