Rompharm Company

What Rompharm Company does

Rompharm Company is a privately held Romanian pharmaceutical manufacturer founded in 2004 and headquartered in Otopeni, Romania. It operates a vertically integrated generics and contract manufacturing organization, producing sterile solutions, injectable ampoules, prefilled syringes, prefilled cartridges, lyophilized (freeze-dried) products, ophthalmics, and solid dosage forms (capsules, powders, granules). The company markets approximately 160 generic pharmaceutical products and operates a portfolio spanning oncology (a 24-product pipeline including Azacitidine, Bortezomib, Docetaxel, Paclitaxel, and others), ophthalmology, and broad therapeutic categories, with stated commercial presence in 60+ countries and 24 European markets. Manufacturing is built on EU GMP-certified facilities, including a dedicated oncology plant and a wholly owned Uzbekistan manufacturing plant both completed in 2024, with aggregate nominal throughput exceeding 100 million prefilled syringes, 100 million ampoules, 110 million secondary packaging/ophthalmic units, 30+ million cartridges, and 20+ million glass-container infusions per year.

Underlying technology centers on aseptic processing, terminal sterilization, lyophilization (with two fully automated lines), prefilled syringe and cartridge filling (including Ready To Use cartiQ formats), and dedicated oncology containment. Rompharm is the Marketing Authorization holder for most products manufactured on-site, with dossiers aligned to EU standards, and runs in-house pharmacovigilance and medical device vigilance functions. Proprietary and differentiated formats include 3.0ml prefilled cartridges (capacity launched 2026), with the company emphasizing personnel training and quality systems over asset ownership as the cornerstone of compliance.

Rompharm monetizes through three revenue streams: direct sales of generic pharmaceutical products (one-time license), in/out licensing of approved products with regulatory support retained (licensing/royalties), and fee-based contract manufacturing under GMP (professional services). Go-to-market is a hybrid model: in CIS countries the company deploys its own medical representatives for direct healthcare-provider engagement, while in the rest of the world it relies on 30 distributor partners and strategic commercial alliances, with an explicit strategic focus on expanding EU sales via licensing and distribution agreements. Customers are healthcare providers, hospitals, pharmacies, and pharmaceutical distributors, supplemented by partner-pharma clients seeking EU-GMP contract manufacturing capacity.

Name

Rompharm Company

Legal name

Rompharm Company

Website

https://rompharm.ro

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

101–250 employees

Short description

Rompharm Company is a Romanian pharmaceutical manufacturer and contract manufacturer of generic medicines, producing sterile injectables, prefilled syringes, lyophilized products, oncology medications, and ophthalmics. It markets roughly 160 products across 60+ countries via distributors, licensing partners, and direct medical representatives in CIS markets.

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Generic Finished Dosage Form (FDF) Manufacturing (HLAIABAH)

akta.pro secondary industries

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Specialty Care Pharmaceuticals (HLAIAAAB)

Keywords

• Generic pharmaceuticals
• Contract manufacturing
• Sterile injectables
• Oncology medications
• Pharmaceutical licensing

Headquarters

HQ city

Otopeni

HQ country

Romania

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Generic Pharmaceutical Products Sales: Rompharm manufactures and sells generic medicines competitive in terms of price and quality, marketing products in 60+ countries
2. Licensing Services: Licensing packages for approved pharmaceutical products available in regions where active ingredients are already authorized. Rompharm manages manufacturing and provides regulatory support while partners handle registration and marketing
3. Contract Manufacturing: Manufacturing services complying with Romanian law no 95/2006 and GMP standards, with Marketing Authorization for most products manufactured on-site

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Rompharm Company manufactures and markets a broad portfolio of generic pharmaceutical products across multiple dosage forms (sterile injectables, prefilled syringes, lyophilized products, ophthalmics, capsules, liquids, powders) and therapeutic categories, with particular specialization in oncology medications. The company additionally provides EU GMP-compliant contract manufacturing services and in/out licensing packages for approved products and dossiers to pharmaceutical partners in regions where active ingredients are already authorized.

Product overview

Rompharm Company is a Romanian pharmaceutical manufacturer offering a diverse portfolio of generic medicines across multiple therapeutic categories. The company provides contract manufacturing services (In/Out Licensing and GMP-compliant contract manufacturing), sterile injectables (solutions, prefilled syringes, vials, freeze-dried products), non-sterile products (capsules, liquids, powders, granules), and a comprehensive oncology pipeline of 24 products. Additional offerings include ophthalmic products and pharmacovigilance services. The company markets approximately 143 products across 60+ countries, with manufacturing capabilities expanded through a new Uzbekistan facility EU GMP inspected in 2024.

Differentiator

Problem solved

Functional benefit

Brands

• Fosfolipiale: Essential phospholipids 250mg/5ml solution for injection - indicated for hepatic steatosis, hepatitis, hepatic cirrhosis, liver failure, liver coma, toxic liver damage, toxicosis of pregnancy, pre- and post-surgical treatment in hepatobiliary area, psoriasis, radiation syndrome.

Products and services

• In/Out Licensing Services Licensing packages for approved pharmaceutical products available in regions where active ingredients are already authorized. The offering includes provision of approved products, global dossiers based on EU standards, high-quality pharmaceutical production, market-specific packaging, and maintenance of marketing authorization. Rompharm manages manufacturing and provides regulatory support while partners handle registration and marketing in their territories.
• Contract Manufacturing GMP-compliant contract manufacturing services for sterile products (aseptically prepared and terminally sterilized), non-sterile products, and quality control testing, performed at EU GMP-certified facilities in compliance with Romanian law no 95/2006 and EC Directive 2003/94/EC.
• Oncology Pipeline Products Comprehensive portfolio of 24 oncology products including Azacitidine, Bendamustine, Bortezomib, Cabazitaxel, Carboplatin, Carfilzomib, Cyclophosphamide, Decitabine, Docetaxel, Doxorubicin, Eribulin, Fluorouracil, Gemcitabine, Irinotecan, Oxaliplatin, and Paclitaxel, manufactured at Rompharm's dedicated oncology products plant completed in 2024.
• Ophthalmic Products Eye drops and ophthalmic solutions including treatments for glaucoma (Latanoprost, Timolol, Bimatoprost, Brinzolamide), infections (Ciprofloxacin, Tobramycin), inflammation (Dexamethasone, Nepafenac), and diagnostics (Tropicamide, Cyclopentolate). Capacity doubled in 2024 to 110 million units per year.
• Sterile Solutions (Injectables) Sterile injectable pharmaceutical products including solutions in ampoules (100 million ampoules/year capacity from 2007 facility), pre-filled syringes (100+ million units/year, 0.3ml to 20ml fill volumes), vials, and freeze-dried products. Manufactured under aseptic and terminal sterilization processes.
• Non-Sterile Products Non-sterile pharmaceutical products including capsules, external use liquids, internal use liquids, powders, and granules in sachets and bottles (dry syrups). Produced at the second facility commissioned in September 2006 for solid dosage forms.
• Pharmacovigilance Services Continuous monitoring of safety of Rompharm's medicinal products throughout their lifecycle, including adverse reaction reporting, monitoring of CE0050 certified medical devices (medical device vigilance), and quality defect reporting for products where Rompharm holds a Marketing Authorization.

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Strategic Partners (EU)coreStrategic or Co-development PartnerRompharm aims to grow sales in the EU market by collaborating with strategic partners. These partnerships focus on expanding market presence in European countries and establishing long-lasting commercial relations with pharmaceutical distributors.

Scale indicators10 records

Recent moves11 records

Expansion highlights6 records

Direct peers

• Gedeon Richter: Hungarian-based pharmaceutical company with a large generics business and growing specialty/oncology franchise, manufacturing sterile and oral dosage forms for global markets. Comparable to Rompharm as a Central/Eastern European generics and specialty injectable producer with multi-country distribution.
• Medochemie: Cyprus-headquartered multinational generic pharmaceutical manufacturer with broad portfolio across multiple dosage forms and significant presence in CIS, Middle East, and African markets. Comparable to Rompharm as a mid-tier generics manufacturer with similar export-driven distribution model targeting emerging markets.
• Krka: Slovenian generic pharmaceutical manufacturer producing prescription generics, OTC products, and animal health products across solid, sterile, and other dosage forms, with strong Central/Eastern European and CIS presence. Directly comparable to Rompharm in scale, regional focus, and product portfolio breadth.
• Polpharma: Polish pharmaceutical manufacturer and one of the largest generics producers in Central and Eastern Europe, with API and finished dosage form manufacturing and broad international distribution. Comparable to Rompharm in regional positioning and vertically integrated generics manufacturing.
• Egis Pharmaceuticals: Hungarian-based generic and specialty pharmaceutical manufacturer producing a wide range of finished dosage forms including injectables and solid orals for Central/Eastern European and CIS markets. Directly comparable to Rompharm in regional positioning, product format mix, and CIS export focus.
• Alvogen: US-based but with significant Central and Eastern European roots and operations, focused on generics and specialty pharmaceuticals including injectables. Comparable to Rompharm as a generics manufacturer with Eastern European heritage targeting similar therapeutic categories and markets.
• Zentiva: Pan-European generic pharmaceutical manufacturer headquartered in Prague with broad portfolio across sterile injectables, orals, and consumer health, and significant Eastern European manufacturing presence. Directly comparable to Rompharm as a European-headquartered generics producer targeting similar markets with similar dosage forms.

Broad incumbents

• STADA Arzneimittel: Large German-headquartered generics and consumer healthcare company with broad product portfolio across Europe and CIS markets, including injectables. Comparable to Rompharm as a broader incumbent in the European generics space with overlapping CIS and EU distribution footprint.
• Sandoz: Novartis's generics and biosimilars division, one of the world's largest producers of generic pharmaceuticals including sterile injectables and complex dosage forms. Comparable to Rompharm as a broad incumbent in the generics and sterile injectable space, though vastly larger in scale and geographic reach.
• Hikma Pharmaceuticals: Global specialty and generic pharmaceutical company with strong injectables franchise and manufacturing in multiple geographies. Comparable to Rompharm as a broader incumbent in sterile injectable generics, though operating at a much larger scale.

Market position

Strengths5 records

Weaknesses3 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 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 Rompharm Company