Patient Centricity

Special API Capabilities

Piramal’s Riverview facility offers High Potency API (HPAPI) services. Our teams are experts in the cGMP production of highly potent compounds, from grams to kilograms. With over 50 years of experience in manufacturing, handling, and containment of highly potent compounds, we prioritize safety and quality in all our operations.

Our facility features high potency manufacturing suites with airlocks and barrier isolation systems for handling compounds with an occupational exposure limit (OEL) of < 1 μg/m3 at kilo-lab scale (as low as 10 ng/m3). With reactor volumes up to 50 L and handling capacities of up to 2 kg, we ensure precise and efficient production processes.

API Services

Featured Services

High Potent API

Piramal’s Riverview facility offers High Potency API (HPAPI) services. Our teams are experts in the cGMP production of highly potent compounds, from grams to kilograms. With over 50 years of experience in manufacturing, handling, and containment of highly potent compounds, we prioritize safety and quality in all our operations.

Our facility features high potency manufacturing suites with airlocks and barrier isolation systems for handling compounds with an occupational exposure limit (OEL) of < 1 μg/m3 at kilo-lab scale (as low as 10 μg/m3). With reactor volumes up to 50 L and handling capacities of up to 2 kg, we ensure precise and efficient production processes

Peptide API

Piramal’s Turbhe facility offers peptide development and manufacturing services. With a 40-year legacy in peptide APIs, we specialize in both solution phase and solid phase synthesis, providing tailored solutions to meet diverse client needs.

Our expertise extends to the manufacturing of cost-effective pseudo-proline building blocks, streamlining peptide synthesis processes. Additionally, we excel in the production of long-chain peptide APIs. With 14 individual production lines capable of operating simultaneously, we ensure efficient and scalable manufacturing to meet our clients’ demands.

We also offer a product portfolio covering almost 90% of all generic peptide APIs.

Hormonal API

With a +40-year legacy in hormonal products, our Morpeth facility in the UK develops and manufactures hormonal APIs. Inspected and approved by global regulatory bodies including the US FDA, UK MHRA, Japan FDA, and others.

 

Controlled Substance

At our Riverview facility in the US, we specialize in the development and manufacturing of Scheduled III, IV, and V controlled substances

Riverview

Riverview is recognized as a world-class facility renowned for its expertise in drug substance manufacturing, with over 60 years of experience in delivering high-potency APIs (HPAPIs). The site has excelled in advancing several HPAPIs from early development to commercial manufacture, solidifying its position as a global leader in API and HPAPI development, as well as GMP manufacturing for complex NCEs.

The site has been fully inspected by numerous regulatory agencies, including USFDA, Health Canada, PMDA Japan, COFEPRIS Mexico, MFDS Korea, TGA Australia, and the Russian Ministry of Health.

Riverview

Drug Substance Development & Manufacturing
Turbhe

Piramal’s Turbhe facility offers strong expertise in the development and commercial manufacturing of both solution phase and solid phase synthesis of peptides. We also offer a portfolio of generic peptide APIs from multigram to kilogram scale. The facility is accredited by USFDA, EDQM, AIFA and KFDA.

Turbhe

Development and Manufacturing of Peptide APIs
Morpeth

Our Morpeth, UK facility is a USFDA and MHRA inspected, fully integrated site which offers Active Pharmaceutical Ingredients (APIs) and oral solid drug product development, clinical supply, commercial manufacturing and packaging services to both innovators and generic pharmaceutical companies.

Morpeth

Development & Manufacturing of Oral Solids and APIs
Riverview

Riverview is recognized as a world-class facility renowned for its expertise in drug substance manufacturing, with over 60 years of experience in delivering high-potency APIs (HPAPIs). The site has excelled in advancing several HPAPIs from early development to commercial manufacture, solidifying its position as a global leader in API and HPAPI development, as well as GMP manufacturing for complex NCEs.

The site has been fully inspected by numerous regulatory agencies, including USFDA, Health Canada, PMDA Japan, COFEPRIS Mexico, MFDS Korea, TGA Australia, and the Russian Ministry of Health.

Riverview

Drug Substance Development & Manufacturing
Turbhe

Piramal’s Turbhe facility offers strong expertise in the development and commercial manufacturing of both solution phase and solid phase synthesis of peptides. We also offer a portfolio of generic peptide APIs from multigram to kilogram scale. The facility is accredited by USFDA, EDQM, AIFA and KFDA.

Turbhe

Development and Manufacturing of Peptide APIs
Morpeth

Our Morpeth, UK facility is a USFDA and MHRA inspected, fully integrated site which offers Active Pharmaceutical Ingredients (APIs) and oral solid drug product development, clinical supply, commercial manufacturing and packaging services to both innovators and generic pharmaceutical companies.

Morpeth

Development & Manufacturing of Oral Solids and APIs
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