Navigation Links
Pharmaceutics International, Inc. (Pii) Successfully Completes EMA and FDA Inspection
Date:8/18/2011

HUNT VALLEY, Md., Aug. 18, 2011 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a leading contract development and manufacturing organization, today announced it has successfully completed the first-ever US-based joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) inspection.  

"Our entire team is very proud of the successful outcome of the joint FDA/EMA inspection," said Tony Horton, vice president of quality assurance at Pii. "This achievement validates our commitment to continuous improvement and our ability to continue to meet the requirements of the FDA, EMA and other international regulatory agencies."

The rigorous four day inspection was conducted by representatives for the EMA from the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Products Agency of Sweden (MPA) and from the FDA. The inspection is part of the FDA and EMA joint initiative, which focuses on increasing international regulatory collaboration among the agencies in order to enhance global drug quality and safety.  

As part of the inspection, Pii's clients received EMA marketing authorization for a soft gel product and reauthorization for a tablet product. Additionally, during the audit the FDA performed an inspection of the company's quality systems as a follow up to its December 2010 inspection for four Pre Approval Inspections. Both FDA inspections have been closed as of June 2011, indicating that Pii is in substantial compliance with US GMPs.

"We are extremely pleased to have achieved this major regulatory milestone," said Steve King, senior vice president of Pii. "This approval allows Pii to continue providing commercial manufacturing services to the global pharmaceutical industry. We look forward to working with our clients to bring several other products to market."

About Pharmaceutics International, Inc.

Pharmaceutics International, Inc. (Pii) is a privately held Drug Delivery Solutions company providing dosage form development and GMP Manufacturing services to the global pharmaceutical industry. Pii's vision is to become the benchmark in pharmaceutical product development outsourcing. Headquartered in Hunt Valley Maryland USA with European facilities in the UK, Pii offers preformulation testing, formulation development and clinical trial material and commercial manufacture of parenteral, solid, semi-solid and liquid dosage forms. For further information about Pii visit www.pharm-int.com.

Contact:
Elizabeth Hickman, Marketing Manager
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
Phone: (443) 858-0768
Email: ehickman@pharm-int.com


'/>"/>
SOURCE Pharmaceutics International, Inc. (Pii)
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. InCode BioPharmaceutics, Inc. Announces Key Data Supporting New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
2. Pharmaceutics International Inc. (Pii) Announces Appointment of Rampurna Prasad Gullapalli, Ph.D. as Vice President of Drug Delivery Technologies
3. Pharmaceutics International, Inc. (Pii) Expands Drug Formulation and Manufacturing Capabilities with Hot Melt Extrusion Technology
4. Arno Therapeutics, Inc. Completes $18 Million Financing and Reverse Merger with Laurier International, Inc.
5. Medizone International, Inc. (MZEI.PK): Trials of the AsepticSure Hospital Sterilization System Have Begun
6. Chindex International, Inc. to Report Second Quarter Fiscal 2010 Financial Results
7. Chindex International, Inc. Reports Second Quarter and First Half Fiscal 2010 Financial Results
8. Natural Alternatives International, Inc. Announces Filing of Patent Infringement Lawsuit
9. DATATRAK International, Inc. Announces Year-End Backlog
10. New Database from ANSI, AAMI, ASTM International, and DIN Provides Centralized Source of Information for Medical Device Professionals
11. DAVISCO Foods International, Inc. and MEGGLE Group Announce a Joint Venture for the Production of Pharmaceutical Lactose.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital ... area economy by obtaining investment capital for emerging technology companies. SCP has ... have already resulted in more than a million dollars of capital investment for ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Finally, a ... after venous procedures, dermaka cream can be incorporated into the post-surgical treatment plans of ... surgical procedures. , dermaka cream is very effective for bruising and causes a ...
Breaking Medicine News(10 mins):