上海奥科达生物医药科技有限公司

What 上海奥科达生物医药科技有限公司 does

Aucta Pharma is a privately held specialty pharmaceutical company developing differentiated medicines through the U.S. FDA 505(b)(2) regulatory pathway and high-barrier branded generics. The company is built around three proprietary drug delivery technology platforms: AucPed™ (pediatric formulations such as oral suspensions), AucTrol™ (controlled/extended-release enabling once-daily dosing, e.g., the world's first once-daily lacosamide), and AucMist™ (nasal delivery for acute发作 and outpatient use). Its commercial portfolio spans CNS drugs (Motpoly XR™ lacosamide extended-release, Oxcarbazepine Oral Suspension, Vigadrone®), rare disease products (Pyquvi™ deflazacort, Zelvysia™ sapropterin for PKU), respiratory products (Formoterol Fumarate Inhalation Solution), and iron overload therapy (Deferasirox Oral Granules).

The company operates a dual China-U.S. footprint with vertically integrated manufacturing at a Shanghai Lingang production base (compliant with both U.S. FDA and China NMPA GMP standards) and a U.S. commercial headquarters in Piscataway, New Jersey. Its go-to-market is hybrid: in the U.S. it deploys a proprietary sales force to market Motpoly XR™ directly (launched 2024 with rapid prescription growth and strong insurance coverage), while pursuing strategic licensing partnerships for international markets outside the U.S. (notably CNS/epilepsy). Revenue is generated primarily from pharmaceutical product sales of branded 505(b)(2) products and branded generics, supplemented by licensing/royalty streams from international partners. Customers are healthcare providers and patients in CNS, rare disease, and metabolic therapeutic areas, with the U.S. payer ecosystem serving as the primary reimbursement channel.

Capital support comes from a syndicate of China- and global-based healthcare-focused investment funds (Grandyangtze, Sangel, Kaifeng, Share Capital, Haida, Sun Bridge), and the company is led by founder/CEO Dr. Li Shoufeng (formerly of Novartis) alongside a management team drawn from Novartis, Pfizer, Sandoz, Purdue, Almirall, Bristol-Myers Squibb and other multinational pharma companies.

Name

上海奥科达生物医药科技有限公司

Legal name

Aucta Pharmaceuticals, Inc.

Website

https://auctapharma.com.cn

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Aucta Pharma is a private specialty pharmaceutical company using the FDA 505(b)(2) pathway and proprietary drug delivery platforms (AucPed™, AucTrol™, AucMist™) to develop branded and high-barrier generic drugs in CNS, rare disease, and metabolic therapeutic areas, commercialized directly in the U.S. and via licensing internationally.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Generic Finished Dosage Form (FDF) Manufacturing (HLAIABAH)

akta.pro secondary industries

Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ), Oral Solid Dose (OSD) Generics (HLAIABAD)

Keywords

• Specialty pharmaceuticals
• 505(b)(2) drug development
• Extended-release formulations
• Rare disease drugs
• CNS therapeutics

Headquarters

HQ city

Piscataway, New Jersey

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Revenue generated from commercializing branded drugs and specialty generic products in the US and international markets through the company's hybrid commercial model
2. 505(b)(2) Enhanced Product Development: Revenue through developing and commercializing improved versions of established molecules via the FDA 505(b)(2) pathway, targeting CNS, metabolic diseases, and rare diseases with differentiated formulations
3. Brand Generic Products: Revenue from high-barrier brand generic products that combine innovative characteristics with generic pricing economics

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Aucta Pharma is an international specialty pharmaceutical company that develops differentiated drugs through the FDA 505(b)(2) pathway and high-barrier branded generics. It commercializes branded epilepsy/CNS products (e.g., MOTPOLY XR™) and rare-disease generics (e.g., Vigadrone®, Pyquvi™, Zelvysia™), supported by three proprietary drug delivery technology platforms (AucPed™, AucTrol™, AucMist™) and vertically integrated manufacturing in Shanghai and New Jersey.

Product overview

Aucta Pharma (上海奥科达) is a specialty pharmaceutical company developing differentiated drugs through the FDA 505(b)(2) pathway and high-barrier branded generics. The product portfolio consists of branded drugs (MOTPOLY XR™), generic drugs (Vigadrone®, Oxcarbazepine Oral Suspension, Pyquvi™, Zelvysia™, Deferasirox Oral Granules), and three proprietary technology platforms (AucTrol™ for controlled release, AucMist™ for nasal delivery, and AucPed™ for pediatric formulations). The company operates a hybrid business model with a US commercial team and strategic international licensing, and has vertically integrated manufacturing capabilities in Shanghai Lingang and New Jersey.

Differentiator

Problem solved

Functional benefit

Brands

• AucPed™: Pediatric drug delivery formulation platform
• AucTrol™
• AucMist™
• MOTPOLY XR™
• Vigadrone®
• Pyquvi™
• Zelvysia™

Products and services

• MOTPOLY XR™ (lacosamide extended-release capsules) World's first once-daily lacosamide extended-release formulation for the treatment of epilepsy and other CNS disorders, marketed in the US via Aucta's own specialty commercial team.
• Vigadrone® (Vigabatrin Powder for Oral Solution) Vigabatrin powder for oral solution indicated for infantile spasms and refractory complex partial seizures, providing a child-friendly alternative dosage form.
• Oxcarbazepine Oral Suspension Oxcarbazepine oral suspension formulation approved by US FDA for epilepsy treatment, offering a liquid alternative to tablets for patients with swallowing difficulties.
• Pyquvi™ (Deflazacort Oral Suspension) Deflazacort oral suspension — a branded generic for rare disease indication (Duchenne muscular dystrophy); first product in Aucta's new rare disease branded generic product line.
• Zelvysia™ (Sapropterin Dihydrochloride Powder for Oral Solution) Saproterin dihydrochloride powder for oral solution indicated for phenylketonuria (PKU), a rare metabolic disorder, providing a powder formulation for improved dosing flexibility.
• Deferasirox Oral Granules Deferasirox oral granules indicated for chronic iron overload conditions, providing a granule dosage form for ease of administration.
• Formoterol Fumarate Inhalation Solution Formoterol fumarate inhalation solution (富马酸福莫特罗吸入溶液) approved by US FDA in 2023 for respiratory conditions, marketed as a specialty inhalation therapy.

Quantifiable outcome

• Motpoly XR™ achieved rapid prescription growth and good insurance coverage following US launch in 2024
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Assertio Holdings: Specialty pharma focused on differentiated branded specialty products in neurology and rare disease. Comparable as a smaller-cap branded specialty company targeting the same physician base Aucta serves in US CNS.
• Supernus Pharmaceuticals: Specialty pharma built around 505(b)(2) reformulations in CNS (epilepsy, ADHD, Parkinson's). Directly comparable: differentiated formulations of known molecules, branded pricing, US-centric commercial team.
• Saptalis Pharmaceuticals: Specialty generics developer focused on complex formulations and 505(b)(2) products in CNS and other niche categories. Comparable niche-formulation strategy and US commercialization model.
• Aprecia Pharmaceuticals: Specialty pharma built around a proprietary drug delivery platform (3D-printed ZipDose). Comparable model: platform-centric formulation tech powering niche CNS and specialty generics like Aucta's AucTrol/AucPed.
• Tulex Pharmaceuticals: Specialty generics developer focused on oral liquid, oral suspension, and other hard-to-formulate generics. Directly comparable to Aucta's AucPed pediatric oral-suspension franchise.
• Novitium Pharma: 505(b)(2) and complex generic developer targeting niche specialty areas. Comparable as another 505(b)(2)-led specialty company competing for share-of-voice with prescribers in the US generics market.
• ANI Pharmaceuticals: Specialty generics and 505(b)(2) developer with branded-generic products in CNS, rare disease, and hospital injectables. Closely comparable branded-generic + niche specialty strategy and US-led commercialization.
• Lannett: US-focused generic pharmaceutical manufacturer with branded-generic exposure, including CNS categories. Comparable vertical from development through US distribution.
• Upsher-Smith Laboratories: Mid-sized specialty generics and branded-generic manufacturer, including CNS products (vigabatrin, oxcarbazepine). Directly overlaps with Vigadrone, Oxcarbazepine OS, and Aucta's CNS-focused branded-generic playbook.

Broad incumbents

• UCB (UCB Pharma): Global CNS-focused innovator pharma and the originator of Vimpat (lacosamide). Relevant as the reference-listed-drug holder whose product Aucta's Motpoly XR was developed around; sets the competitive benchmark in US epilepsy.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/%E4%B8%8A%E6%B5%B7%E5%A5%A5%E7%A7%91%E8%BE%BE%E7%94%9F%E7%89%A9%E5%8C%BB%E8%8D%AF%E7%A7%91%E6%8A%80%E6%9C%89%E9%99%90%E5%85%AC%E5%8F%B8

Compliance1 record

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 →

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