About Airis Pharma

Healthcare with a mission.

At Airis Pharma, we develop the complex generic medicines patients depend on and partners cannot afford to get wrong. Every dossier is engineered for analytical rigor, regulatory predictability, and supply certainty — so the partners who license our science can deliver it to market with confidence.
Integrated Partnerships

The full CDMO chain — orchestrated, not outsourced.

Airis is not a stand-alone analytical lab handing off a paper filing. We are the orchestration layer for the entire complex generic value chain — from custom API synthesis through commercial-scale manufacturing.

01 Tier-1 API Layer

Tier-1 API partnerships engineered for custom DMF programs.

Airis maintains long-standing tier-1 partnerships with Maithri Labs, Divi's Laboratories, and Laurus Labs — relationships that extend beyond off-the-shelf API supply into custom synthesis and DMF co-development. When a program demands a non-commodity API route, we work with our partners from impurity-profile design through DMF filing — ensuring API and formulation move in lockstep rather than sequentially.

3
Tier-1 API houses · long-standing relationships
DMF
Co-development from impurity profile through filing
API & formulation developed in parallel — not sequentially
02 Commercial CMO Layer

Three strategic CMO partnerships covering the full spectrum of complex generic manufacturing.

Beyond development, Airis operates three formalized, audit-ready CMO partnerships — each chosen for distinct commercial-scale strengths. Together they span the full breadth of complex generic dosage forms: oral solids, oral liquids, sterile injectables, lyophilized products, oncology cytotoxics, softgels, and high-potent containment.

A partner who licenses an Airis dossier inherits not just the filing — but a pre-qualified, audit-ready manufacturing path from day one. No CMO-hunting, no tech-transfer guesswork, no scale-up risk transferred onto the licensor.

Manufacturing coverage across the partner network

USFDA · EU GMP · WHO-GMP Approved
Dosage form
Network coverage
Oral solids · tablets & capsules
● ● ●  Multi-partner redundancy at commercial scale
Sterile injectables · liquid vials
● ●  Two specialized partners · BOSCH filling line
Lyophilized injectables
● ●  Two partners · Martin Christ ALUS lyophilizer
Oncology · cytotoxic OSD
● ●  Dedicated USFDA-approved oncology facilities
High-potent · OEB-4 / OEL-5 containment
● ●  GEA contained granulation · isolator technology
Pre-filled syringe (PFS)
●  Dedicated specialist partner
Oral liquids & suspensions
●  Vertically-integrated CDMO · ~1B units/year capacity
Softgel capsules
●  Dedicated softgel line · oncology & nutraceutical
NRT · chewing gums & lozenges
●  Proprietary integrated manufacturing process
The CDMO Loop · Closed End-to-End

One orchestration layer. Five connected stages.

From custom API development through regulator-cleared dossier and into commercial manufacturing — every stage handled inside the Airis network. Partners who license our science inherit a complete, de-risked path to market.

STAGE 01
Custom API development
Tier-1 partner co-development & DMF filing
STAGE 02
Formulation R&D
QbD execution across complex dosage forms
STAGE 03
Analytical method science
Method development, validation & transfer
STAGE 04
Regulator-cleared dossier
USFDA, MHRA, Health Canada filing & review
STAGE 05
Commercial manufacturing
Pre-qualified CMO partner network