Xiromed

Name

Xiromed

Legal name

Xiromed, LLC

Website

https://xiromed.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Medicinal and Botanical Manufacturing (325411)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Small-Molecule Generics (Branded/Unbranded) (HLAIABAA)

akta.pro secondary industries

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ), Complex Generics (e.g., inhalation, transdermal, liposomal) (HLAIABAB), Sterile Injectable Generics (HLAIABAC), Topical & Dermatology Generics (HLAIABAE), Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO)

Keywords

• Generic pharmaceuticals
• Oral contraceptives
• Women's health generics
• Oncology injectables
• Hormonal injectables

Headquarters

HQ city

Florham Park

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Generic Pharmaceutical Product Sales: Xiromed generates revenue through the development, approval, and commercialization of generic pharmaceutical products in the US market across oral solids, topicals, injectables, and contraceptives. Revenue is realized through product sales to wholesalers, retail pharmacies, hospital systems, and GPOs, with pricing influenced by market exclusivity periods (180-day CGT designation), reference brand pricing, and competitive landscape.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Xiromed is a US-based generic pharmaceutical company and the American generics division of Insud Pharma, S.L. (Madrid, Spain). The company develops, manufactures, and commercializes a diverse portfolio of FDA-approved generic pharmaceutical products across four dosage forms: Oral Solids, Topicals, Contraceptives, and Injectables. The portfolio is heavily weighted toward women's health (oral contraceptives, fertility treatments, hormone replacement therapies), with additional strength in oncology injectables, institutional injectables, dermatology topicals, and other therapeutic categories.

Product overview

Xiromed is a US-based generic pharmaceutical company and the American subsidiary of Insud Pharma S.L. (Madrid, Spain). The company develops and commercializes a diverse portfolio of high-quality generic pharmaceutical products for the US market across four main dosage forms: Oral Solids, Topicals, Contraceptives, and Injectables. Xiromed's commercial portfolio centers on women's health and hormonal products, with particular strength in oral contraceptives (including first-to-market generics like Joyeaux® for Balcoltra® and Gemmily™ for Taytulla®), fertility treatments (Progesterone Capsules, Progesterone Vaginal Insert, Ganirelix Acetate), and hormone replacement therapies (Estradiol products). The company also offers oncology injectables (Docetaxel, Fluorouracil, Fulvestrant, Irinotecan, Melphalan), topical medications (Betamethasone, Clobetasol, Ketoconazole, Naftifine), and other therapeutic categories including proton pump inhibitors, cardiovascular drugs, and antibiotics. Xiromed has achieved multiple first-to-market generic approvals and Competitive Generic Therapy (CGT) designations from the FDA. The company's pipeline includes complex generics, injectables (hormonal, oncology, and long-acting), topical, respiratory, and drug-device combination products. Manufacturing capabilities are supported by Insud Pharma's facilities in Spain and India, with dedicated hormonal injectable production at Laboratorios Farmalan in Leon, Spain.

Differentiator

Problem solved

Functional benefit

Brands

• Abigale™: Estradiol Hemihydrate / Norethisterone Acetate Tablets for hormone replacement therapy
• Altavera®
• Betamethasone Valerate 0.12% Foam
• EnilloRing®
• Estarylla®
• Gemmily®
• Joyeaux®
• Loryna®
• Volnea®
• Tri-Estarylla®
• Tri-Lo-Estarylla®
• Ganirelix Acetate Injection
• Progesterone Vaginal Insert 100mg
• Ramelteon Tablet
• Fulvestrant Injection
• Testosterone Cypionate Injection

Products and services

• Progesterone Vaginal Insert 100mg First-to-market generic vaginal progesterone insert for assisted reproductive technology (ART) fertility treatment, supporting embryo implantation and early pregnancy. 100mg with applicators, 21 tablets per pack.
• Joyeaux First-to-market generic oral contraceptive with ferrous fumarate supplement. Levonorgestrel/ethinyl estradiol 0.1mg/0.02mg + ferrous fumarate, 3 x 28 pack. Generic to Balcoltra.
• Gemmily First-to-market generic oral contraceptive softgel capsules. Norethindrone acetate/ethinyl estradiol 1mg/20mcg in 3 x 28 pack. Generic to Taytulla.
• EnilloRing Contraceptive vaginal ring containing etonogestrel and ethinyl estradiol. 120mcg/15mcg release rate, 1 x 3 pack. Generic to Nuvaring.
• Estradiol Gel 0.1% Transdermal hormone gel for treatment of moderate to severe vasomotor symptoms due to menopause. Available in 30-packs of 0.25g, 0.5g, 0.75g, 1.0g, and 1.25g packets. Generic to Divigel.
• Fulvestrant Injection Estrogen receptor antagonist for treatment of breast cancer. 250mg/5mL (50mg/mL) in 2 X 5mL pre-filled syringes. Generic to Faslodex.
• Ephedrine Sulfate Injection USP 50mg/mL Alpha- and beta-adrenergic agonist for treatment of clinically important hypotension occurring in anesthesia. 50mg/mL in 1mL vials. Generic to Akovaz.
• Ganirelix Acetate Injection 250mcg/0.5mL Pre-Filled Syringe GNRH antagonist pre-filled syringe for inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. 250mcg/0.5mL pre-filled syringe.
• Docetaxel Injection USP Antineoplastic agent for cancer treatment. Available in 10mg/mL concentration in 2mL single-dose, 8mL and 16mL multi-dose vials. Generic to Taxotere.
• Fluorouracil Injection USP Antimetabolite antineoplastic agent. Available in 50mg/mL concentration in 10mL single-dose, and 50mL and 100mL multi-dose vials. Generic to Adrucil.
• Testosterone Gel 1.62% Topical testosterone gel for hormone replacement. 1.62% (20.25mg/1.25gm actuation) in 88gm bottle delivering 75gm of gel. Generic to AndroGel.
• Phytonadione Injectable Emulsion USP 10mg/mL Vitamin K1 injection for treatment of coagulation disorders. 10mg/mL in 25 x 1mL ampules.
• Betamethasone Valerate Foam 0.12% Medium potency topical corticosteroid foam for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Available in 50g and 100g cans. Generic to Luxiq.
• Testosterone Cypionate Injection USP Injectable testosterone for hormone replacement in males. Available in 100mg/mL multi-dose vial and 200mg/mL single-dose and multi-dose vials. Generic to Depo-Testosterone.
• Oral Contraceptive Portfolio (20+ products) Portfolio of 20+ oral contraceptive products including monophasic, biphasic, triphasic, and quadriphasic formulations in standard, chewable, and softgel capsule formats. Branded products include Altavera, Estarylla, Volnea, Vienva, Loryna, Syeda, Jaimiess, LoJaimiess, Introvale, Joyeaux, Gemmily, Tri-Estarylla, Tri-Lo-Estarylla, Feirza, Luizza, Galbriela, Rosyrah, Valtya, Xarah FE, Xelria FE, Meleya, Orquidea, Isibloom, Gallifrey, and Abigale.

Quantifiable outcome

• First FDA-approved generic with CGT designation for Progesterone Vaginal Insert 100mg (generic to Endometrin®), eligible for 180-day CGT market exclusivity
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered minor and core.

• Aggrega PharmaminorStrategic or Co-development Partner · 17 July 2023Aggrega Pharma is a pharmaceutical company developing, manufacturing, and marketing generic medications (injectable, ophthalmic, oral, and topical finished dosage forms) with shareholders including Bluepharma, Rafarm, Substipharm, and Welding. Xiromed partnered with Aggrega Pharma for the co-development and launch of Ephedrine Sulfate Injection USP, 50 mg/mL (generic to Akovaz®), with Aggrega managing product development and Xiromed handling US commercialization. Aggrega Pharma's vast R&D, clinical, and manufacturing experience of its member companies supports the partnership's pipeline of complex generics.
• Gland Pharma LtdminorStrategic or Co-development PartnerXiromed entered into a strategic collaboration with Gland Pharma Ltd. Gland Pharma is an Indian pharmaceutical company specializing in sterile injectable generics. The collaboration was announced in 2020 and likely involves development and supply of generic injectable products for the US market.
• Viatris (Women's Healthcare Business Acquisition)coreOthersInsud Pharma successfully closed the acquisition of Viatris' Women's Healthcare business in March 2024. The acquired business primarily relates to oral and injectable contraceptives. The deal strengthens Xiromed's women's health portfolio, adds two manufacturing plants to the group's network, and expands presence in emerging markets. This acquisition was a landmark transaction that significantly broadened Xiromed's product offering in women's healthcare.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Alvogen: US-focused specialty generics company with strength in women's health, oncology, and complex generics. Comparable as an emerging player with overlapping therapeutic focus, particularly in hormonal and injectable products where both companies compete.

Direct peers

• ANI Pharmaceuticals: US specialty generics company focused on orphan, women's health, and complex generics including injectables and hormonal products. Comparable as a direct competitor in the women's health and specialty injectable space with similar institutional channel focus.
• Amneal Pharmaceuticals: US-focused generic and specialty pharmaceutical company with significant presence in injectables, oral solids, and complex generics. Comparable in that it targets similar institutional and retail channels and competes directly on many of the same molecules, including injectables and women's health products.
• Lannett Company: US generic pharmaceutical manufacturer with broad portfolio across oral solids, injectables, and topical products. Comparable in that it serves the same wholesale-driven distribution model and targets similar therapeutic areas including women's health and institutional injectables.
• Upsher-Smith Laboratories: Private US generic pharmaceutical company with portfolio spanning women's health, dermatology, and central nervous system products. Comparable as a private, mid-sized US generics player with similar channel strategies and therapeutic focus overlap.
• Mayne Pharma: Specialty pharmaceutical company with generics and branded women's health portfolio (oral contraceptives, hormone therapies). Comparable as a competitor in women's health generics with similar therapeutic specialization.
• Padagis: US-focused generic pharmaceutical company (formerly Perrigo's generics business) offering topical, oral, and specialty generics. Comparable in that it competes on similar dosage forms and targets overlapping retail and institutional customers.

Broad incumbents

• Sandoz: Recently spun off from Novartis, Sandoz is one of the largest global generic pharmaceutical companies with significant US presence. Comparable as a broad incumbent competing across injectables, oral solids, and complex generics, including women's health.
• Viatris: Global generics and specialty pharmaceutical company formed via Mylan-Upjohn combination. Comparable as a broad incumbent and notably the seller of the Women's Healthcare business that Insud Pharma acquired in 2024, indicating direct portfolio overlap with Xiromed.
• Teva Pharmaceutical Industries: World's largest generic drug manufacturer with extensive US generics portfolio across all dosage forms and therapeutic areas. Comparable as a broad incumbent that competes with Xiromed across virtually all product categories but at vastly greater scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/xiromed-llc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Xiromed