ANI Pharmaceuticals Reports Second Quarter Results

Wednesday, August 7, 2019 General News
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ANI Pharmaceuticals, Inc. and Subsidiaries

Table 5: Cortrophin® Gel Re-Commercialization Milestone Update

Objective

Duration

Steps / Details

Status

Manufacture commercial-scale batches of corticotropin API 

2-3 months per batch

• Scale-up manufacturing process 5x to projected commercial scale

Complete

• Finalize API manufacturing process & initiate PV / registration batches

Complete

• Method development for API characterization methods

Complete

• Method validation for API release / stability methods

Complete

• Perform viral clearance studies and validation

In Progress

Manufacture Commercial Scale Cortrophin® Gel Drug Product

1 month per batch

• Finalize drug product manufacturing process

Complete

• Initiate process validation

Complete

• Method validation for API release / stability methods

In Progress

• Manufacture three API and three drug product registration batches

Two Complete / Third In Progress

Registration stability for sNDA

6 months

• Initiate registration stability studies and demonstrate six-months of accelerated and real-time stability prior to sNDA submission

First two studies initiated and in progress / Third awaiting batch manufacturing

sNDA submission

• Target date: 1Q 2020

• Filing - four month PDUFA date

On Track



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