Manufacturing Solutions
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Manufacturing Solutions and Services
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Manufacturing Solutions and Services
PIHS offers comprehensive pharmaceutical manufacturing solutions, from early clinical candidates to commercial supplies. With facilities in India and Italy, we ensure reliable, scalable, and cost-effective production of APIs and HPAPIs, supporting life cycle management. Our certified sites deliver high-quality, regulatory-compliant manufacturing to meet global standards.
Clinical Supply (phase 1,2,3)
Our Lodi, Milan site ensures reliable clinical supply across phases 1-3, with scalable manufacturing, advanced reactors, and specialized capabilities for APIs and anti-cancer products.
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Expertise in large-scale deacylated phospholipid production, cytostatic nucleosides, chromatographic purification, and handling OEB4 potency levels ensures seamless commercial API and intermediate manufacturing.
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Advanced Manufacturing & Global Compliance
PIHS stands out for its expertise in the large-scale production of Deacylated Phospholipids (GPC, GPE) and proficient handling of pyridine and pyridine-SO3 complexes. It excels in cytostatic manufacturing and drying of nucleosides, and chromatographic purification using ionic resins, operating up to OEB4 potency levels. PIHS’s quality system aligns with EU GMP Part II and ICH Q7 standards, utilizing Trackwise™ for managing deviations, out-of-specifications (OOS), CAPA, and change control. It supports global compliance with 24 active Drug Master Files in 39 countries and 4 active Certificates of Suitability (CEP) for the US/EU markets.
Certified for Excellence in Pharma
PI Health Sciences holds several certifications and accreditations, including an API Registration Form (AMA-50/2020), GMP Certificate for Human use (IT-API/104/H/2020), GMP Certificate for Veterinary use (NBF/31/2020V), FEI Number 3002874947, and DUNS Number 429351620. It is accredited by the US FDA, with the last inspection in April 2017, AIFA, with the most recent inspection in February 2024, KFDA (Korea), last inspected in October 2011, and the Ministry of Health for Veterinary, last inspected in June 2019.
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Our team is committed to partnering with you and supporting your goals and objectives across the pharma value chain.