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NerPharMa operates as a CDMO bringing highly potent compounds to the marketplace
NerPharma has brought new products and unique innovative technologies to the market over the years, delivering a wide range of GMP services through its agile and flexible facilities.
NerPharMa owns a wide and cutting edge organizational structure able to manage and handle highly active compounds, and to ensure the full development and production of active principles and finished products intended for the world market as well as the research and development of innovative formulation and delivery systems.
In Nerpharma there are two divisions:
NerPharMa DS (drug substance) and NerPharMa DP (drug product)
The two divisions operate in accordance with Current Good Manufacturing Practices (cGMP) and are authorized by the most relevant authorities: Italian Drug Agency (AIFA), U.S. Food and Drug Administration (FDA), ANVISA Brazil, China FDA, PMDA Japan and Russia for the production of both pharmaceutical active ingredients and finished products.
NerPharma operates worldwide and with more than 30 customers
Product
We have more than 15 products on the market and three unique innovative technologies approved in the last two years.
Expertise
With our deeply and multidiscipilinary expertise we can support our customers in developing and implementing New Chemical Entities and innovative formulations from the scratch.
About us
We support our customer in every step of the process by providing multiple services including
the production of the active ingredient and its formulation, packaging, clinical supply chain management, and obtaining regulatory approvals in the various countries.
NerPharMa operates since 2010 and our strong specialisation in oncology, our competence and experience make us able to optimise the entire development process till the launch of the product on the market.
From API to drug Product
Nerpharma has two separate divisions:
NerPharma DP (Drug Product)
can support the development and production of injectable products (solutions, suspensions and lyophilized products) and oral solid products (tablets and capsules) for different therapeutic areas, by handling Proteine Kinase Inibitors, cytotoxic and cytostatic products (not only oncological) and with formulation, packaging and distribution activities.
NerPharMa DP operates in accordance with Current Good Manufacturing Practices (CGMP) and is authorised to manufacture and package Medicinal Products issued by the Italian Regulatory Agency (AIFA).
NerPharMa DS (Drug Substance)
develops and manufactures exclusively product for oncology (Protein Kinase Inibitor, cytotoxic/cytostatic), from laboratory scale to commercial.
NerPharMa DS operates in accordance with Current Good Manufacturing Practices (CGMP) and is authorised to manufacture of high potent drug substances by the Italian Regulatory Agency (AIFA).
Services
NerPharMa provides a fully integrated and multidisciplinary support to its customers in order to meet the project milestones on time and with high quality standards.
Development
and scale-up
We take care of pharmaceutical forms development based on the active ingredient supplied by the customer or manufactured by NerPharma DS, following every phase of the process, from the laboratory to patient kits assembly, the industrialization phase up to the launch of the product on the market.
Contract Manufacturing
We guide complex compounds securely and efficiently from development through commercial manufacture.
Regulatory Services
We offer to our partners guidance and consulting in IMPD, IND, DMF, CMC and dossier preparation and filing.
Clinical Supply
We take care of packaging products used by hospitals for clinical studies. We combine patient kits, consisting of the primary and associated drug.
Analytical Services
Thanks to our excellent analytical instrumentation, our laboratory is able to develop specific methods to certify and release any type of product on the market.
Latest News & Events
NerPharMa Appoints Claudio Salvagnini as Deputy CEO
Nerpharma is pleased to announce the appointment of Claudio Salvagnini as the Deputy CEO, effective immediately.
Since Claudio joined the leadership team earlier this year, he has been a driving force in the recent turning around NerPharMa. As the Deputy CEO, he will play a critical role in shaping the company’s strategic direction and ensuring operational efficiency.
(Click the title for the complete article)
SIMIS Srl Announces Nomination of Laurent Contaut as the new CEO of SIMIS, a company part of NMS Group
SIMIS Srl (SIMIS), a NMS Group company, is pleased to announce the appointment of Laurent Contaut as the new Chief Executive Officer (CEO) of the organization, effective immediately. The appointment of Laurent comes at an exciting time for SIMIS, as the company continues to expand its services and drive innovation in the pharmaceutical and biotech industries.
(Click the title for the complete article)
NerPharMa Appoints Vittorio Montanaro as New Head of Quality to Strengthen Commitment to Excellence
NerPharMa Srl (part of NMS group), a leading Contract Development and Manufacturing Organization (CDMO), is pleased to announce the appointment of Vittorio Montanaro as new Head of Quality, effective immediately. In this role, Vittorio will lead the Quality Assurance, Quality Control and Regulatory Affairs to ensure the highest standards of quality, safety and compliance across NerPharMa’s extensive range of services, offered through both Drug Substances and Drug Product divisions. Vittorio will cover also the role of Qualified Person.
(Click the title for the complete article)
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