Research & Development
Pharmaceutics International announces US FDA's EIR
15 March 2019 -

Pharmaceutics International Inc (Pii) said on Thursday that it has received the US Food and Drug Administration's (FDA) Establishment Inspection Reports (EIRs) for its facilities in Hunt Valley and Cockeysville, MD.

The company stated the FEI registration numbers (1000513101/3006503102), cover facilities in Hunt Valley and Cockeysville, MD. The EIRs are related to General and Pre-Approval Inspections (PAIs) that occurred between 23 October and 9 November 2018, of non-sterile and sterile drug production facilities.

Both the EIRs indicate that Pii and its facilities Pii are in an acceptable state of compliance.

Following the US FDA's inspection and facility status recommendation, the company has been awarded the US FDA's approval of four sterile and non-sterile products.

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 and a Contract Development and Manufacturing Organization (CDMO).

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