Le Lézard
Classified in: Health
Subject: FDA

Pharmaceutics International Receives EIR from FDA


HUNT VALLEY, Md., March 14, 2019 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) today announced that the U.S. Food and Drug Administration (FDA) has issued their Establishment Inspection Reports (EIRs) for both FEI registration numbers (1000513101/3006503102), covering Pii's facilities in Hunt Valley and Cockeysville, MD.  The EIRs are related to General and Pre-Approval Inspections (PAIs) that occurred between October 23rd and November 9th, 2018, of non-sterile and sterile drug production facilities.  Both EIRs indicate that Pii's facilities are at "voluntary action indicated" or VAI status, which means the Agency found Pii to be in an acceptable state of compliance.  Subsequent to the FDA's inspection, and facility status recommendation, Pii has gained the FDA's approval of 4 sterile and non-sterile products.

Pharmaceutics International, Inc, (PRNewsFoto/Pharmaceutics International, Inc)

"The successful completion of the FDA facility inspection is a very positive development for Pii, as we continue on our journey to meet and exceed U.S. and international regulatory requirements.  Pii will continue to address observations noted during the inspection, and strive for the highest standard of product quality, compliance and customer service," said Dr. Kurt Nielsen, Pii's President and CEO. 

About Pharmaceutics International, Inc.

Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances.  For more information, please visit www.pharm-int.com.

Contact: 
Kurt R. Nielsen, Ph.D., President and CEO 
Pharmaceutics International, Inc. 
10819 Gilroy Road 
Hunt Valley, MD 21031 
Phone: (410) 584-0001 
Email:  knielsen@pharm-int.com

SOURCE Pharmaceutics International, Inc.


These press releases may also interest you

at 11:33
BIOREM Inc. ("BIOREM" or "the Company") today announced new orders totalling $5.7 million.  The orders are for air emission abatement projects in China and North America. "Our focus for business development over the last couple of years has been...

at 11:20
ELITechGroup Inc., known for worldwide transformation and innovation of sweat testing with the Webster Sweat Inducer and Macroduct® Sweat Collection System, endorsed by the U.S. Cystic Fibrosis Foundation and other global CF associations, announces...

at 11:20
FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced positive Phase 1 results from the healthy volunteer arm of an ongoing study of FT-4202, a novel selective red blood...

at 11:15
Precision NanoSystems (PNI) announced today that it has been selected as a finalist in this year's Fierce Innovation Awards ? LifeSciences Edition, a peer reviewed awards program from the publisher of FierceBiotech and FiercePharma.  The competition...

at 11:10
Growing demand for therapeutic antibodies and increasing biopharmaceutical R&D activities are expected to drive the chromatography resin market. Read the full report: https://www.reportlinker.com/p05830800/?utm_source=PRN  The global chromatography...

at 11:05
Xellia Pharmaceuticals (?Xellia'), a global leader in the manufacturing of specialty anti-infective treatments, has launched the latest product in what is now marketed as its VANCO READYTM range of room temperature stable, ready-to-use (RTU)...



News published on 14 march 2019 at 10:20 and distributed by: