Dipharma S.A.
Dipharma S.A. is a Swiss specialty pharmaceutical company that develops and commercializes improved generic drugs for rare metabolic diseases (PKU, Gaucher, Niemann-Pick, HT-1, Urea Cycle Disorders), distributing room-temperature stable formulations via regional partners and direct sales in Germany.
- Company typePrivate
- Founded2016
- HeadquartersChiasso, Switzerland
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Dipharma S.A. does
Dipharma S.A. is a Swiss specialty pharmaceutical company, founded circa 2016 by Marc-Olivier Geinoz and headquartered in Chiasso, that develops and commercializes improved generic medicines for rare metabolic diseases. Its portfolio comprises four core products: Sapropterin Dipharma (for hyperphenylalaninemia/PKU and BH4 deficiency), Miglustat Dipharma (for Gaucher disease type 1 and Niemann-Pick type C), Nitisinone Dipharma (for hereditary tyrosinemia type 1), and Carglumsäure Waymade (carglumic acid, for hyperammonemia in Urea Cycle Disorders), supplemented by branded regional products such as Diterin® (South Korea) and Disanit® (EU). The core technical differentiator is formulation chemistry: Dipharma holds granted US patents on Miglustat (synthesis method US9079856B2 and crystalline form US8802155B1) and has filed international patents on a stable crystalline Nitisinone and stable capsule formulations, enabling room-temperature-stable presentations (up to 36 months for Miglustat and 2-3 years for Nitisinone) that eliminate the cold-chain requirements of originator products like Orfadin® and Zavesca®.
The company monetizes through a partner-based commercialization model: it supplies the active pharmaceutical ingredient and finished product to regional licensees/distributors (Amerigen for US Miglustat, Analog Pharma for US Nitisinone, Alvogen for South Korea, LogixX Pharma for UK Sapropterin, EffRx for Switzerland) and maintains direct field-sales presence only in Germany through its subsidiary Dipharma Arzneimittel GmbH. Pricing is quote-based, varies by market and payer, and is not publicly disclosed; in the US, patient assistance programs bring Nitisinone copays as low as $0. Approvals span FDA, EMA (centralized authorization in 31 EEA countries), MHRA, Swissmedic and Korean MFDS, with further registrations pending in Southeast Asia, the Middle East and Latin America.
The company operates with a small, capital-light footprint, leveraging the manufacturing and chemistry expertise of the founder's family CDMO group (Dipharma Francis Srl, Italy/USA) rather than owning large-scale production assets. It is privately held, has no disclosed external funding rounds, and is led by founder/CEO Marc-Olivier Geinoz, supported by an HR Director (Angela Tanieli). Customer segments are end-patient populations with rare inborn errors of metabolism, accessed indirectly through specialty pharmacies and national health systems, with payer cost pressure on orphan drugs providing the primary demand driver for affordable generic alternatives.
Dipharma S.A. firmographics
Firmographics- Name
- Dipharma S.A.
- Legal name
- DIPHARMA SA
- Website
- https://dipharma.ch
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Dipharma S.A. is a Swiss specialty pharmaceutical company that develops and commercializes improved generic drugs for rare metabolic diseases (PKU, Gaucher, Niemann-Pick, HT-1, Urea Cycle Disorders), distributing room-temperature stable formulations via regional partners and direct sales in Germany.
- Ownership category
- akta.pro rank
Dipharma S.A. industry classification
Industry- Product category
- Specialty 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)
Keywords
Where Dipharma S.A. is headquartered
LocationHeadquarters
- HQ city
- Chiasso
- HQ country
- Switzerland
- HQ region
- Europe
Offices2 records
Markets served
Dipharma S.A. business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Product sales of generic orphan drugs: Dipharma SA generates revenue through the sale of improved generic pharmaceutical products for rare metabolic diseases, including Sapropterin Dipharma, Miglustat Dipharma, Nitisinone Dipharma, and Carglumsäure Waymade. Products are sold across multiple markets including EU, Switzerland, UK, USA, South Korea, and other regions through a network of commercial partners and direct sales in Germany.
- Licensing and co-development agreements: Revenue is generated through licensing agreements with partners such as Amerigen, Analog Pharma, Alvogen, and LogixX Pharma. These partners commercialize Dipharma's products in specific territories (e.g., Amerigen for US Miglustat, Analog for US Nitisinone, Alvogen for South Korea) under exclusive collaboration agreements. Dipharma supplies the active pharmaceutical ingredient and receives licensing fees or revenue share.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Multi-year contract | Nitisinone Capsules (2mg, 5mg, 10mg, 20mg) - US market via Analog Pharma |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
Dipharma S.A. product offering
Product offeringCore offering
Dipharma SA develops, manufactures, and commercializes improved generic pharmaceutical products for rare metabolic diseases. Its portfolio includes Sapropterin Dipharma (for PKU/BH4 deficiency), Miglustat Dipharma (for Gaucher Disease Type 1 and Niemann-Pick Type C), Nitisinone Dipharma (for Hereditary Tyrosinemia Type 1), and Carglumsäure Waymade (for Urea Cycle Disorders). The company differentiates through proprietary room temperature stable formulations, superior purity, and bioequivalent delivery compared to originator orphan drugs.
Product overview
Dipharma S.A. is a Swiss specialty pharmaceutical company focused on developing and commercializing improved generic medicines for rare metabolic diseases. The company offers a portfolio of four core products: Sapropterin Dipharma (for Phenylketonuria and BH4 deficiency), Miglustat Dipharma (for Gaucher disease and Niemann-Pick Type C), Nitisinone Dipharma (for Hereditary Tyrosinemia Type 1), and Carglumsäure Waymade (for Urea Cycle Disorders). These are supported by branded regional products including Diterin® (South Korea) and Disanit® (EU). The company differentiates through improved formulations, particularly room temperature stability, and operates through a network of commercial partners globally.
Differentiator
Problem solved
Functional benefit
Brands
- Diterin: Brand name for Sapropterin Dihydrochloride 100mg tablets, indicated for treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU).
- Disanit
- Sapropterin Dipharma
- Miglustat Dipharma
- Nitisinone Dipharma
Products and services
- Sapropterin Dipharma (Diterin® in South Korea) Sapropterin Dihydrochloride 100mg soluble tablets and 100mg/500mg sachets for oral solution. A synthetic version of naturally occurring 6R-BH4 cofactor used to treat Hyperphenylalaninemia (HPA) in Phenylketonuria (PKU) patients and BH4 deficiency. Marketed as Diterin® in South Korea.
- Miglustat Dipharma Miglustat 100mg hard capsules. A glucosylceramide synthase inhibitor providing substrate reduction therapy for Gaucher Disease Type 1 and Niemann-Pick Disease Type C. Approved in EU, USA, and Switzerland. Can be stored at room temperature for 36 months.
- Nitisinone Dipharma (Disanit® in Europe) Nitisinone 2mg, 5mg, 10mg, and 20mg hard capsules. A competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase for treatment of Hereditary Tyrosinemia Type 1 (HT-1). Room temperature stable formulation with 2-year shelf life (extended to 3 years for 20mg capsules). Marketed as Disanit® in Europe.
- Carglumsäure Waymade Carglumsäure (Carglumic acid) 200mg tablets for oral suspension. A structural analog of N-acetylglutamate for treatment of hyperammonemia due to primary N-acetylglutamate synthase deficiency (Urea Cycle Disorders). Approved in selected EU countries.
Quantifiable outcome
- Miglustat Dipharma is the first generic version of Zavesca approved in the US and EU
- +5 more outcomes
Companies that use Dipharma S.A.
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
Dipharma S.A. technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Dipharma S.A. partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered minor and core.
- LogixX PharmaminorDipharma introduced an improved and protective packaging solution for its Sapropterin products, specifically designed for Far East countries. This aligns with high quality standards and improved solutions for patients.
- LogixX PharmacorePartnership with LogixX Pharma for the launch of Sapropterin Dihydrochloride in the United Kingdom. The MHRA granted Marketing Authorization for Sapropterin in June 2023, and the official UK launch was announced in October 2023. LogixX Pharma handles commercialization in the UK market.
- Analog Pharma (member of Duchesnay Pharmaceutical Group)coreAdditional FDA approval for 20 mg Nitisinone capsules (temperature stable). With the approval of the 20 mg capsule, Analog now has a full complement of room temperature stable strengths. The 20 mg is the most commonly prescribed strength of Orfadin®, bringing American HT-1 patients a room temperature stable treatment option. Available to eligible patients for as little as $0 per prescription. Stability at room temperature extended to 3 years for the 20 mg capsule.
- Analog Pharma (member of Duchesnay Pharmaceutical Group)coreCollaboration for FDA approval of Nitisinone ANDA (2, 5, 10 mg). Analog Pharma received final FDA approval for room temperature stable, AB-rated generic equivalent of Swedish Orphan Biovitrum's Orfadin® (Nitisinone capsules). Analog expects to distribute the product through specialty pharmacies beginning in Q3 2022. Dipharma's Nitisinone is bioequivalent to Orfadin® but can be stored at room temperature for 2 years.
- EffRx Pharmaceuticals SAcoreDistribution agreement for Miglustat Dipharma in Switzerland. EffRx Pharmaceuticals SA is a company specialized in the commercialization of orphan drugs and distributes Miglustat Dipharma 100 mg capsules in Switzerland. The agreement marks another milestone in Dipharma's mission to offer improved solutions to patients suffering from inborn errors of metabolism.
- Amerigen PharmaceuticalscoreExclusive collaboration between Amerigen and Dipharma in developing and commercializing Miglustat 100 mg capsules worldwide. Amerigen's ANDA for Miglustat 100 mg capsules received final FDA approval as the first generic equivalent to Actelion's Zavesca®. Amerigen's affiliates manufacture the finished product and commercialize it in the US, where it has already been launched. Dipharma supplies the miglustat active ingredient and holds two granted US patents (US9079856B2, US8802155B1). Amerigen has the right to enforce these patents in the US.
- AlvogencoreExclusive collaboration agreement between Dipharma S.A. and Alvogen for the commercialization of Diterin® (Sapropterin Dihydrochloride 100mg tablets) in the South Korean market. Alvogen holds exclusive rights to commercialize Diterin® 100mg tablets in Korea. Diterin® is the only drug approved in South Korea by the Korean Ministry of Food and Drug Safety for the treatment of HPA due to PKU. Dipharma is working to make Diterin® available in all countries worldwide.
- Dipharma Arzneimittel GmbHcoreGerman subsidiary company (wholly owned or controlled) located in Limburg an der Lahn, Germany. Represents Dipharma's direct commercial presence in the German market. Phone: +49 (0)6431-284 3201.
Scale indicators5 records
Recent moves6 records
Expansion highlights5 records
Dipharma S.A. competitors and assessment
Company assessmentBroad incumbents
- Recordati Rare Diseases: Specialty division of Recordati focused on rare and orphan diseases, with overlapping metabolic-disease portfolio and global distribution infrastructure. Comparable business model of addressing unmet needs in rare diseases through specialty pharmaceutical offerings.
- Ultragenyx Pharmaceutical: US-based rare-disease biopharmaceutical company developing and commercializing therapies for metabolic and other rare genetic disorders. Comparable as a rare metabolic disease-focused commercial-stage company competing for the same specialist physician audience and payer budgets.
- Teva Pharmaceutical Industries: World's largest generic drug manufacturer with broad specialty and rare-disease exposure. Comparable as a potential competitor in generic orphan drugs and as a benchmark for global generic-pharma commercial scale that Dipharma accesses only through partners.
- BioMarin Pharmaceutical: Originator of Kuvan (sapropterin) for PKU and broader rare-disease leader. Directly competes with Dipharma's Sapropterin Dipharma in PKU and represents the branded incumbent whose market share Dipharma is targeting with its generic alternative.
- Swedish Orphan Biovitrum (Sobi): Originator of Orfadin (Nitisinone) and broader rare-disease specialty pharma. Operates in the same therapeutic categories as Dipharma and competes directly through its branded Nitisinone franchise while also pursuing adjacent metabolic and hematology rare diseases.
- Aurobindo Pharma: Large Indian generic pharmaceutical manufacturer with extensive US and EU ANDA portfolios, including rare-disease products. Comparable as a competitor that could file ANDAs against Dipharma's molecules and as a benchmark for global generic-pharma scale and capital intensity.
- Actelion Pharmaceuticals (Janssen/J&J): Originator of Zavesca (miglustat) for Gaucher disease and Niemann-Pick Type C. Now part of Janssen Pharmaceuticals. Competes with Dipharma's Miglustat Dipharma through the branded reference product that Dipharma's generic has been approved against.
Others
- Dipharma Francis Srl: Related-family CDMO with four cGMP manufacturing sites in Italy and the USA, founded on the same Geinoz/Biazzi family heritage as Dipharma SA. Not a direct competitor but an ecosystem enabler that supplies manufacturing infrastructure and small-molecule API expertise underpinning Dipharma's product portfolio.
Direct peers
- Polpharma Biologics: Polish-based developer and manufacturer of generic and biosimilar medicines with activity in specialty and rare-disease segments. Comparable as a European-headquartered specialty generics manufacturer pursuing complex small-molecule opportunities.
- Cycle Pharmaceuticals: UK-based specialty pharma that develops improved formulations of existing drugs for rare diseases, with a focus on patient-friendly delivery and stability. Highly comparable to Dipharma in business model (improved generics for rare metabolic and orphan conditions) and target customer base (specialists and payers seeking better alternatives to originator orphan drugs).
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Dipharma S.A. social profiles
Digital presenceDipharma S.A. financial estimates
Financial estimateRevenue estimate
Valuation estimate
Dipharma S.A. leadership team
Management profileNumber of profiles
Profiles4 records
Dipharma S.A. funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Dipharma S.A. M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Dipharma S.A.
What does Dipharma S.A. do?
Dipharma SA develops, manufactures, and commercializes improved generic pharmaceutical products for rare metabolic diseases. Its portfolio includes Sapropterin Dipharma (for PKU/BH4 deficiency), Miglustat Dipharma (for Gaucher Disease Type 1 and Niemann-Pick Type C), Nitisinone Dipharma (for Hereditary Tyrosinemia Type 1), and Carglumsäure Waymade (for Urea Cycle Disorders). The company differentiates through proprietary room temperature stable formulations, superior purity, and bioequivalent delivery compared to originator orphan drugs.
Is Dipharma S.A. a public or private company?
Dipharma S.A. is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Dipharma S.A. founded?
Dipharma S.A. was founded in 2016. It employs 11 to 50 people.
Where is Dipharma S.A. based?
Dipharma S.A. is headquartered in Chiasso, Switzerland, in the Europe region.
How does Dipharma S.A. make money?
Two revenue lines are on record. Product sales of generic orphan drugs are the primary driver. The others are licensing and co-development agreements.
Who are Dipharma S.A.'s main competitors?
Broad incumbents on record are Recordati Rare Diseases, Ultragenyx Pharmaceutical, Teva Pharmaceutical Industries, BioMarin Pharmaceutical, Swedish Orphan Biovitrum (Sobi), Aurobindo Pharma and Actelion Pharmaceuticals (Janssen/J&J). Dipharma Francis Srl is listed as an others. Direct peers are Polpharma Biologics and Cycle Pharmaceuticals.
Does Dipharma S.A. have an API?
No public API is recorded for Dipharma S.A..
What industry is Dipharma S.A. in?
Dipharma S.A.'s product category is Specialty Pharmaceuticals. Its primary akta.pro industry code is HLAIABAA, Small-Molecule Generics (Branded/Unbranded). Its NAICS code is 32541 and its SIC code is 2833.