API Manufacturing Services
Introduction
PI Health Sciences acquired Archimica in year 2023 to support generic pharmaceutical companies with quality compliant & niche Generic APIs designed for scalability, reliability, sustainability, regulatory compliant with made in Europe supplies. Our capabilities span market-ready commercial APIs and flexible API-on-request, covering therapeutic areas like antipsychotic, anticancer, antiacid, antiulcers and supported by strong GMP systems and global regulatory filings. With proven quality oversight and decades of technical expertise, we deliver dependable drug substance solutions for generic pipelines. Whether you require validated commercial APIs or specialized molecules produced on demand, our team ensures seamless supply, quality, consistent performance and timely response to our partners needs.
PI Health Sciences’ Lodi site integrates analytical laboratories, process development, and GMP manufacturing to deliver scalable, high-quality APIs for global supply.
Our Generic API Portfolio
Our commercial API offering provides a robust portfolio of GMP-compliant molecules backed by strong global regulatory support. We supply validated, high-quality APIs across major therapeutic areas with consistent batch performance and dependable delivery.
| Product Name | Category | EUDMF | USDMF |
|---|---|---|---|
| Cytarabine (nucleoside analogue) | Anticancer | - | - |
| Hydroxyurea (modified urea) | Anticancer | - | - |
| Mianserin (tetracyclic) | Antipsychotic | - | - |
| Pirenzepine Dihydrochloride | Anticholinergic | Approved | Approved |
| Sucralfate (saccharose sulfate) | Antiacidic / Antiulcer | - | - |
| Disopyramide | Antiarrhythmic | Approved | - |
| Sulfathiazole (sulfonamide) | Antiinfective | - | - |
| Sucrose octasulfate potassium salt | Antiulcers | - | - |
| Glycerophosphoryl-Choline (GPC) | Anti-Alzheimer / Cognition Enhancer | - | - |
| Glycero Phosphoryl Ethanolamine (GPE) | Anti-Alzheimer / Cognition Enhancer | - | - |
| Product Name | Category | EUDMF | USDMF |
|---|---|---|---|
| Bromfenac | Anti-inflammatory | Approved | Approved |
| Capecitabine | Antineoplastic/Anticancer | Approved | Approved |
| Citicoline | Neuroprotective | Approved | - |
| Dihydralazine sulfate | Antihypertensive | Approved | - |
| Hydralazine hydrochloride | Antihypertensive | Approved | Approved |
| Lithium Carbonate | Antimanic | Approved | Approved |
| Oxcarbazepine (dibenzazepine) | Anticonvulsant/ Antiepileptic | - | - |
| Sulfapyridine | Antibiotic | Approved | Approved |
| Thenfadil | Antihistamine | Approved | - |
| Tolmetin | Anti-inflammatory | Approved | - |
Our Capabilities
GMP Commercial & Specialty API Manufacturing
Audited, traceable, and compliance-driven global logistics.
Regulatory-Ready DMF & Filing Support
Comprehensive EUDMF and USDMF documentation packages, including CEP-supported commercial APIs.
Flexible Custom Manufacturing
Custom batch manufacturing aligned to specific project needs and molecule complexity.
Integrated Analytical & Technical Support
Analytical and technical support through development and commercialization.
Seamless Scale-Up Capability
Efficient scale-up from pilot to commercial supply ensuring long-term readiness.
Accreditations
AIFA
US-FDA
KFDA (Korea)
Veterinary Ministry of Health
Frequently asked questions
We’re here to help with any questions you have about plans, pricing, and supported features.
What types of APIs does PI Health Sciences supply through Archimica?
How does API-on-request differ from standard commercial API supply?
Commercial APis are validated, pre-established molecules designed for predictable, long-term supply. API-on-request programs are built for flexibility, supporting niche chemistry, customized batch sizes, and development-stage needs, with structured scale-up from pilot to commercial volumes and full CEP or USDMF support.
Are the APIs suitable for global regulatory submissions and market supply?
Yes. All APIs are manufactured under GMP systems with documentation structured for global regulatory use. Depending on the molecule and program stage, support includes CEPs, USDMFs, and EUDMFs, enabling seamless integration into filings across Europe, the US, and other regulated markets.
How does PI Health Sciences ensure supply reliability and batch consistency?
Insights & Resources
Insights from across our services
Contact Us
Connect with PI Health Sciences to explore how our customized pharmaceutical development services can streamline your molecule’s journey from concept to market with precision and confidence.