PIRAMAL PHARMA SOLUTIONS ANNOUNCES PRODUCTION OF FIRST BATCHES AT NEW API FACILITY IN RIVERVIEW, MICHIGAN

• New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
• Adds significant manufacturing capacity to support customer demand
• Culmination of "Project PRIME Phase 1" - a $38M investment program begun in 2021

MUMBAI, India, Feb. 15, 2023 /CNW/ -- Piramal Pharma Solutions, a patient-centric Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd (PPL, NSE: | BSE: 543635), today announced that it has begun production of initial batches of active pharmaceutical ingredients (APIs) in new reactor suites at its facility in Riverview, Michigan, USA.

Construction of the capacity expansion at Riverview, known as Project PRIME (Piramal Riverview Integrated Manufacturing Expansion) Phase 1, was kicked off in May of 2021. The initial production run is the culmination of a capital expenditure of $38 million in equipment and construction costs. The facility covers approximately 25,000 square feet of space and includes production, warehousing and supporting utilities. It is readily scalable to accommodate additional reactor bays, which are planned as part of Project PRIME Phase 2.

The featured technology in the new facility is 10 kl of reactor capacity accompanied by a pressure dryer filter. The reactors are capable of producing high potency APIs with low Occupational Exposure Levels (OELs) of >1μg/m3.

The initial production batches represent the first step in a three-step process for the development and manufacturing of Phase II clinical trial materials. As part of the program, Piramal technicians are scaling up material from 10-15 kg to 75-80 kg.

According to Peter DeYoung, Chief Executive Officer, Piramal Global Pharma, "Getting Project PRIME Phase 1 online is an important milestone for Piramal Pharma Solutions and the Riverview site team. It brings additional capacity to our North American offering, which we believe satisfies the market's current high demand for APIs. It also addresses the industry trend for onshoring of drug substance production. When coupled with the recent expansion of our API capabilities in Aurora, Canada, we believe that we are ready and able to support the market with both potent and non-potent APIs, from clinical to commercial scale."

The recently completed expansion at Piramal's API site in Aurora, Ontario, was part of a CAD $30 million capital investment. The new plant features more than ten thousand square feet of manufacturing and utility space and includes two new reactor suites with additional filtration and drying capabilities.

About Piramal Pharma Solutions: 

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug product. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies we believe makes us a partner of choice for innovator and generic companies worldwide. 

For more information visit: www.piramalpharmasolutions.com | Facebook | Twitter  | LinkedIn

About Piramal Pharma Ltd:

Piramal Pharma Limited (PPL, NSE: PPLPHARMA | BSE: 543635), offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market and a minority investment in Yapan Bio. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.

For more information visit: www.piramal.com/pharma | Facebook | Twitter | LinkedIn

Disclaimer:

Piramal Pharma Limited is proposing, subject to receipt of requisite approvals, market conditions and other considerations, a rights issue of its equity shares in the near future, and intends to file a draft letter of offer with the Securities and Exchange Board of India.

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SOURCE Piramal Pharma Limited