What Norbitec Gmbh does

Norbitec GmbH is a German biopharmaceutical contract manufacturer specializing in the production of Erythropoietin (Epoetin zeta), a recombinant human protein used as an active pharmaceutical ingredient for treating anemia and supporting dialysis patients. Founded in 2003 as a Joint Venture, the company operates as a subsidiary of BIOCEUTICALS Arzneimittel AG — itself jointly owned by STADA Arzneimittel AG and Nordmark Pharma GmbH — and is co-located with Nordmark Pharma at its Uetersen facility in the Hamburg metropolitan area. The company holds central European marketing authorization (December 2007) for biosimilar products Silapo and Retacrit, and received FDA approval (April 2023) for US-market API manufacturing.

Norbitec's production technology relies on mammalian cell culture using genetically modified CHO (Chinese Hamster Ovary) cells. The industrial-scale process spans cell cultivation, production fermentation, cell separation, product concentration, and purification, all conducted under GMP conditions audited by EMA and FDA. The company employs approximately 100-125 staff including skilled professionals, university graduates, and career starters, and maintains active quality management and quality assurance systems aligned with both EU and US regulatory specifications.

The business model is B2B pharmaceutical ingredient manufacturing: Norbitec produces Epoetin zeta API and supplies it to pharmaceutical company partners who market the finished biosimilar products Silapo and Retacrit globally. Revenue is generated through direct enterprise sales to these partners under confidential commercial terms, with no public pricing disclosure. The company has no direct consumer-facing activity and does not own the downstream drug product brands. Its geographic reach spans Europe (since 2007) and the United States (since April 2023), with no disclosed external funding rounds and stable ownership within the STADA/Nordmark group since inception.

Name

Norbitec Gmbh

Legal name

Norbitec GmbH

Website

https://norbitec.de

Company type

Private

Founded year

2003

Operating status

Operating

Short description

Norbitec GmbH is a German biopharmaceutical manufacturer that produces Erythropoietin (Epoetin zeta) active ingredient for treating anemia, supplying pharmaceutical partners who market the biosimilars Silapo and Retacrit globally under EU EMA and US FDA approvals.

Ownership category

akta.pro rank

Product category

Biopharmaceutical API Manufacturing

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Erythropoietin (EPO) Biosimilars (HLAIAFAC)

Keywords

• Biopharmaceutical API manufacturing
• Erythropoietin production
• Recombinant protein manufacturing
• Biosimilar active ingredients
• GMP cell culture production

Headquarters

HQ city

Uetersen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Ingredient Manufacturing: Manufacturing and sale of Erythropoietin (Epoetin zeta) as pharmaceutical active pharmaceutical ingredient (API) to pharmaceutical companies. Products are used in anemia treatment and for dialysis patients.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Norbitec GmbH develops and biotechnologically manufactures Erythropoietin (Epoetin zeta), a recombinant active pharmaceutical ingredient (API) used for the treatment of anemia and for dialysis patients. The company produces the API at industrial scale using mammalian cell culture with genetically modified CHO cells, supplying pharmaceutical companies that market finished biosimilar drug products under brand names such as Silapo and Retacrit.

Product overview

Norbitec GmbH is a biotech pharmaceutical company specializing in the production of Erythropoietin (Epoetin zeta), a biotechnologically manufactured active pharmaceutical ingredient for treating anemia. The company operates with four interconnected educational/production support resources: Epoetin zeta (the core product), an educational resource explaining what erythropoietin is, quality management/quality assurance information, and production process documentation. The finished drug products containing Epoetin zeta are marketed under the brand names Silapo and Retacrit.

Differentiator

Problem solved

Functional benefit

Products and services

• Epoetin zeta A biotechnologically manufactured active pharmaceutical ingredient (API) of Erythropoietin (Epoetin zeta), produced in mammalian cells through recombinant DNA technology using genetically modified CHO (Chinese Hamster Ovary) cells. Sold as an API to pharmaceutical companies that formulate and market finished biosimilar drug products (e.g., Silapo and Retacrit) used for the treatment of anemia and for dialysis patients.

Quantifiable outcome

• Central European market authorization December 2007 for Silapo and Retacrit
• +1 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered core.

• Silapo / Retacrit Marketing PartnerscoreChannel Partner/ Reseller/ Distributor · 1 January 2007Pharmaceutical products Silapo and Retacrit containing Epoetin zeta manufactured by Norbitec are marketed by pharmaceutical partners. European Commission authorized these products in December 2007.
• Nordmark Pharma GmbHcoreStrategic or Co-development Partner · 1 January 2003Co-founding parent company alongside STADA Arzneimittel AG. Norbitec is located on the premises of Nordmark Pharma GmbH in Uetersen. Partnership includes shared infrastructure and pharmaceutical manufacturing ecosystem.

Scale indicators4 records

Recent moves5 records

Expansion highlights3 records

Broad incumbents

• Amgen: Amgen is the originator of Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and a dominant incumbent in erythropoiesis-stimulating agents. Comparable as the benchmark therapeutic class incumbent against which biosimilar manufacturers like Norbitec compete.
• Roche: Roche markets NeoRecormon (epoetin beta), a major originator ESA. Comparable as a broad incumbent in the therapeutic class in which Norbitec's Epoetin zeta competes.
• STADA Arzneimittel AG: STADA is Norbitec's parent and the direct marketer of Silapo (containing Norbitec's Epoetin zeta). Comparable as both the controlling parent and a generic pharmaceutical major that channels Norbitec's API output into finished biosimilar products.

Direct peers

• Biocon Biologics: Biocon Biologics is a leading global biosimilar manufacturer with an approved Epoetin alfa biosimilar. Comparable to Norbitec as a biosimilar API manufacturer serving global pharmaceutical partners with mammalian cell-derived biologics.
• Pfizer (Hospira): Pfizer, through its Hospira heritage, is both a customer for Norbitec's Epoetin zeta (marketed as Retacrit) and a competitor with its own biosimilar portfolio. This dual role makes it a uniquely comparable peer in the biosimilar EPO supply chain.
• Sandoz (Novartis): Sandoz markets Binocrit, a competing biosimilar Epoetin alfa, directly against Norbitec-supplied biosimilars. Both operate in the biosimilar erythropoiesis-stimulating agents (ESA) market with overlapping molecules and customer base.
• Samsung Bioepis: Samsung Bioepis is a major biosimilar developer using CHO cell-based mammalian expression systems. Comparable in technology platform and target customer base (global pharma partners seeking biosimilar supply).
• Rentschler Biopharma: Rentschler is a German-based CDMO specializing in mammalian cell culture (CHO) for biologics and biosimilars. Directly comparable as a contract manufacturing peer using the same upstream technology platform.
• Boehringer Ingelheim BioXcellence: Boehringer Ingelheim's BioXcellence business is a major CDMO for biologics including biosimilars, using mammalian cell culture. Comparable as a peer offering biosimilar manufacturing services to pharma clients.
• Intas Pharmaceuticals (Accord Healthcare): Intas/Accord markets Erypro, a competing biosimilar Epoetin alfa, and operates a vertically integrated biologics manufacturing footprint. Comparable as a biosimilar erythropoietin producer and supplier.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/norbitec-gmbh

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Norbitec Gmbh