New Mandate– Seeking partnership for FDA approved Manufacturing facilities in the US for controlled substance APIs & formulations

Published : 14 Jun 2022


Aagami has bagged an assignment to find and establish Partnerships for FDA approved Manufacturing facilities in the US for the controlled substances APIs & formulations.

 

For this assignment, a large global consulting firm approached Aagami for support on behalf of the end client. This is a validation of the fact that Aagami has earned credibility not only with life sciences companies, but also from the Top consulting companies of the world.

 

The client’s facilities host manufacturing & development capabilities in controlled substance APIs & formulations. Below is the overview of capabilities and value proposition.

Plant 1 Location: West Coast USA

Segment: APIs

Capabilities:

  • FDA/DEA approved facility
  • End to end services including API R&D, manufacturing, analytical development etc.
  • Covers a range of scales from lab to kilo lab to pilot plant to commercial scale
  • Capable of safely handling up to Category 3 potent compounds (on the SafeBridge® Banding Scale)

 

Plant 2 Location: Midwest USA

Segment: Formulations

Capabilities: 

  • FDA/DEA approved facility
  • Formulation facility with OSD, semisolids and nasal spray manufacturing capabilities
  • Capacity to manufacture 700 million ++ pills per year
  • Equipped with Osmotic Controlled Release Oral Delivery (OROS) technology
  • Serialization capability for semisolid, liquid and oral solid packaging
  • Dedicated vaults for potent substance storage; separate area for flammable material storage

If you would like to know more about this opportunity for engaging/utilizing these facilities through manufacturing/leasing partnership, please contact us.

 

Contact details:

 

Godwyn Francis

Vice President

M: +1-630-909-3341 

Email: godwyn@aagami.com

 

Aagami, Inc.                                               

2020 Calamos Court, Suite 200

Naperville IL 60563

P:  +1-630-364-1837

 

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