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:10/11/2017)... PARK, Calif. , Oct. 11, 2017  BioPharmX ... national scientific team that developed an innovative way to ... quantity of the delivery of new drugs. ... 2017 Fall Clinical Dermatology Conference will show how researchers ... General Hospital, Harvard Medical School used a suite of ...
(Date:10/11/2017)... , Oct. 11, 2017  True Health, a ... amplified its effort during National Breast Cancer Awareness ... cancer risks. ... Oncology calculated that more than 10 million American ... mutations in BRCA1 or BRCA2 and have not had ...
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... in the greater Dallas, Miami, and Raleigh regions, is organizing an extended charity ... a rare and deadly chromosome abnormality. , After struggling since birth with several ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association of Eating ... excellence for the field of eating disorders, announces the opening of early registration ... Orlando, Florida at the Omni Resort at ChampionsGate. , The annual ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
Breaking Medicine News(10 mins):