Newchem

What Newchem does

Newchem S.p.A. is an Italian pharmaceutical manufacturer founded in 1998 and headquartered in Milan, specializing in the production of Active Pharmaceutical Ingredients (APIs) across three therapeutic categories: corticosteroids, hormones, and prostaglandin analogues. The company's commercial portfolio comprises 54 registered APIs — including Betamethasone, Budesonide, Dexamethasone, Cyproterone acetate, Dienogest, Latanoprost, and Bimatoprost — manufactured at two GMP-compliant production facilities in Verona (11,430 m², 30 reactors) and Pavia (6,630 m², 19 reactors), supplemented by a 700 m² R&D facility staffed by 24 scientists with an active pipeline of nine investigational APIs. Distribution is direct B2B to global pharmaceutical manufacturers across 47-51 countries and 5 continents, supported by extensive regulatory filings (17 EDMF, 18 KDMF, 18 USDMF, 14 JDMF, 20 CEP) and approvals from AIFA, FDA, PMDA, KFDA, and ANVISA. Pricing is quote-based and not publicly disclosed, with revenue generated through transactional API sales under long-tenure customer relationships.

Since October 2017, Newchem has operated as a subsidiary of Zhejiang Xianju Pharmaceutical Co. Ltd., a Chinese pharmaceutical group founded in 1972 and listed on the Shenzhen Stock Exchange since 2010. Leadership transitioned in April 2023 when Carlo Cartasegna (also Deputy General Manager of the parent group) was appointed CEO, succeeding Speranza Carletti; this was followed by a June 2023 relocation of the registered office to Via San Vittore 39, Milan. The company maintains a branch office in Mumbai, India, and pursues enterprise field sales via participation in major industry events including CPHI Worldwide, CPHI China, CPHI Japan, CPHI India, DCAT Week, and DDL Edinburgh. The only documented technology partnership of note is a June 2021 collaboration with iGenius to deploy an AI-powered virtual advisor ('crystal') for sales-team business intelligence access — a peripheral productivity tool rather than a core differentiator.

Name

Newchem

Legal name

NEWCHEM S.P.A.

Website

https://newchemspa.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

Newchem S.p.A. is an Italian manufacturer of Active Pharmaceutical Ingredients (corticosteroids, hormones, prostaglandin analogues) producing 54 GMP-certified APIs across two Italian facilities for global pharmaceutical manufacturers in 47-51 countries, operating as a subsidiary of China's Zhejiang Xianju Pharmaceutical since 2017.

Ownership category

akta.pro rank

Product category

Pharmaceutical API Manufacturing

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Medicinal and Botanical Manufacturing (325411)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Small-Molecule API Commercial Manufacturing (HLAGAHAB)

akta.pro secondary industry

Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Active pharmaceutical ingredients
• API manufacturing
• Corticosteroid APIs
• Hormone APIs
• GMP pharmaceutical production

Headquarters

HQ city

Milano

HQ country

Italy

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Active Pharmaceutical Ingredients (API) Sales: Newchem generates revenue through the manufacture and sale of active pharmaceutical ingredients (APIs) including corticosteroids, hormones, and prostaglandin analogues. The company produces 54 registered APIs sold in 47-51 countries worldwide. Revenue is generated through direct B2B sales to pharmaceutical companies.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Newchem manufactures and sells 54 registered Active Pharmaceutical Ingredients (APIs) covering corticosteroids, hormones, and prostaglandin analogues, produced under GMP at its Verona and Pavia facilities in Italy and distributed to pharmaceutical customers in 47–51 countries across 5 continents. It also operates a 700 m² R&D center developing additional investigational APIs through custom synthesis and process scale-up. The company holds extensive regulatory filings (CEP, USDMF, JDMF, KDMF, EDMF, CDMF, CADIFA, CBPF) and is approved by AIFA, FDA, PMDA, KFDA, and ANVISA.

Product overview

Newchem S.p.A. is an Italian pharmaceutical company founded in 1998 and part of the Zhejiang Xianju Pharmaceutical Group (since October 2017). Its core product is a portfolio of 54 Active Pharmaceutical Ingredients (APIs) — spanning corticosteroids, hormones, and prostaglandin analogues — manufactured at two GMP-compliant production facilities in Verona and Pavia, Italy, and distributed to approximately 47–51 countries worldwide. The company also maintains a dedicated R&D pipeline of products under development. Newchem does not operate a software platform; its offering is entirely in the manufacture and supply of pharmaceutical APIs.

Differentiator

Problem solved

Functional benefit

Products and services

• Active Pharmaceutical Ingredients (APIs) — corticosteroid, hormone, and prostaglandin analogue portfolio Portfolio of 54 GMP-manufactured Active Pharmaceutical Ingredients spanning three therapeutic categories: corticosteroids (e.g., Betamethasone, Budesonide, Clobetasol, Dexamethasone, Fluticasone, Hydrocortisone, Methylprednisolone, Mometasone, Prednisolone, Triamcinolone variants — 36+ products), hormones (e.g., Cyproterone acetate, Desogestrel, Dienogest, Drospirenone, Estetrol, Gestodene, Nomegestrol acetate, Tibolone, Ulipristal acetate — 10+ products), and prostaglandin analogues (Bimatoprost, Beraprost sodium, Iloprost, Latanoprost, Latanoprostene Bunod, Limaprost, Travoprost). Manufactured at GMP-compliant facilities in Verona and Pavia, Italy, and supplied to pharmaceutical formulators in approximately 47–51 countries across 5 continents; supported by DMF/CEP filings in US, EU, Japan, Korea, China, and Brazil.

Quantifiable outcome

• 54 registered APIs produced and sold across 47-51 countries
• +1 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• iGeniuscoreTechnology or Integration · 21 June 2021Newchem partnered with iGenius to deploy 'crystal', an AI-powered virtual advisor for business intelligence. The solution enables Newchem's sales team to access real-time business data via voice commands on smartphones, improving operational efficiency and data-driven decision making. A 30-day pilot demonstrated the platform's ability to simplify data access without requiring technical training.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Hovione: Portugal-based CDMO and API manufacturer with facilities in Europe, US, and Asia, producing complex small-molecule APIs under GMP. Comparable as a specialty API manufacturer serving global pharma with strong regulatory capabilities.
• EUROAPI: Paris-listed European API manufacturer spun out from Sanofi producing branded and generic APIs including corticosteroids and hormones. Comparable as a GMP API manufacturer serving global pharma customers with regulatory dossiers across multiple geographies.
• Centrient Pharmaceuticals: Netherlands-based manufacturer of sustainable antibiotics, statins, and anti-fungals as APIs, supplying pharma customers globally with extensive DMF/CEP filings. Comparable as a European-headquartered specialty API manufacturer with deep regulatory dossiers.
• Farmabios: Italian API manufacturer owned by the Borregaard Group, producing corticosteroids, hormones, and steroid intermediates at GMP facilities in Italy. Most direct comparable by geography, therapeutic focus (steroids/hormones), and business model.
• Shandong Xinhua Pharmaceutical: Hong Kong-listed Chinese manufacturer of APIs including corticosteroids, hormones, and caffeine products, with extensive global distribution. Directly comparable by therapeutic focus (steroids/hormones) and as a low-cost Asian API peer in overlapping molecule categories.

Broad incumbents

• Curia (formerly AMRI): US-headquartered CDMO offering API manufacturing and drug product services globally, owned by Acquired US Holdings. Comparable as a global small-molecule API manufacturer serving pharma with multi-jurisdiction regulatory filings.
• Siegfried Holding: Swiss-listed CDMO offering both API manufacturing (including steroids and hormones) and finished drug product services globally. Comparable as a diversified API manufacturer serving pharma with European GMP footprint and broad regulatory approvals.
• Cambrex: US-headquartered CDMO (owned by Permira) producing small-molecule APIs and intermediates with facilities in the US and Europe. Comparable as a global API manufacturer with strong regulatory and quality capabilities, though broader in scope than Newchem's specialty focus.
• Divi's Laboratories: India-listed leading manufacturer of APIs and intermediates with strong presence in corticosteroids, hormones, and peptides, supplying global generics. Comparable as a major low-cost API manufacturer competing in overlapping therapeutic categories.
• Johnson Matthey (Health sector): UK-listed specialty chemicals group with an API and fine chemicals division producing small-molecule APIs including controlled substances. Comparable as a large diversified manufacturer with GMP API capabilities, though broader in scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/newchem-spa

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Newchem