Airis Pharma is a scientifically driven execution partner focused on complex, high-barrier generics. We operate at the intersection of analytical rigor, IP navigation, and bioequivalence confidence to unlock molecules others choose not to pursue.
Three disciplines, executed by seasoned scientists who own complex generic programs end-to-end — from molecule selection to regulatory approval.
Quality-by-Design applied selectively to de-risk formulation, scale-up, and BE performance — translating R&D complexity into predictable, regulator-ready outcomes.
Proven track record executing complex Paragraph IV, NCE-1, and non-infringing development strategies across USFDA, MHRA, Health Canada, and select emerging markets.
Deep hands-on experience delivering complex dossiers with a focus on regulator-quiet approvals — minimizing review cycles, maximizing predictability.
Aurobindo, Biocon, MSN and other leading developers partner with Airis for the dossiers that have to land cleanly the first time.
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.
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.
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.
An integrated CDO platform spanning formulation development, analytical method science, stability, and regulatory submission — purpose-built for complex molecules.
From simple tablets to complex injectable formulations — high-quality drug products engineered for performance, safety, and regulatory compliance.
Airis Pharma specializes in transforming innovative concepts into safe, effective, and scalable pharmaceutical products. From simple tablets to complex injectable formulations, we focus on developing high-quality drug products that meet the diverse needs of the pharmaceutical industry.
Our formulation development services cover a wide array of dosage forms, advanced drug delivery technologies, and robust equipment capabilities — all built around performance, safety, and regulatory compliance.
Cutting-edge technologies applied selectively under Quality-by-Design (QbD) principles — translating R&D complexity into predictable, regulator-ready outcomes. Sound expertise developing First-to-File, Paragraph IV, NCE, and non-infringing formulations across USFDA, MHRA, Health Canada, and emerging markets.
Two dedicated wings — Formulation Research (476 sq. ft.) and Analytical Research (956 sq. ft.) — supported by 120 KVA backup power, dedicated UPS systems, and controlled-RH environments. Every photo on this page is the actual Airis R&D floor.
An R&D laboratory of 5,000 sq. ft. across two dedicated wings — Formulation Research and Analytical Research — fully equipped for oral solids, liquids, semi-solids, and simple injectables. Utilities: 120 KVA electricity with 2× 120 KVA backup generators; 2× 60 kW UPS; 5 HP & 15 HP compressed air.
The Analytical Quality Services (AQS) unit — the engine room behind every dossier Airis files.
Analytical development is where complex generic programs are won or lost. Methods that hold up at validation, dissolution profiles that match the reference, impurity work that survives FDA review — this is the science that determines whether a dossier files clean or stalls in deficiency cycles. Airis's analytical laboratory has supported regulated-market filings since 2014, with two USFDA inspections cleared and a track record built molecule by molecule.
Discriminating, stability-indicating methods purpose-built for each molecule.
End-to-end execution aligned with ICH Q2(R1), USP <1225>, and FDA guidance.
ICH-aligned programs across long-term, accelerated, and intermediate conditions.
Discriminating dissolution development and routine release on qualified USP apparatus.
ID, quantification, and structural confirmation across related substances and degradants.
Full physicochemical testing across the complex generic supply chain.
Analytical method science travels with the program. When a partner moves from R&D to clinical to commercial scale, our methods, specifications, and reference standards transfer cleanly to the receiving site — preserving years of accumulated learning instead of forcing a rebuild.
Direct support for product registration dossiers across USFDA, MHRA, Health Canada, and emerging markets — including analytical sections of CTD modules, response to deficiency letters, and post-approval change defense.
Bioanalytical method support for bioequivalence and clinical programs, with continuity of analytical thinking from formulation development through pivotal BE study readout.
The lab is registered with USFDA (FEI 3012071812; DUNS 650864775), with registration valid through December 2026. Two USFDA inspections — Jan 2017 (NAI · Zero 483) and Feb 2024 (VAI · EIR received) — both cleared. The lab is also audited and approved by CDSCO.
Our method development isn't just about getting a clean chromatogram in our lab — it's about building methods robust enough to survive transfer to partner QC sites without rework. That's the difference between a method that closes one filing and a method that scales across a franchise.
API testing, in-process control, finished product release, stability, and BE-supporting bioanalytics — all under one regulator-audited roof. Partners don't manage multiple analytical vendors with conflicting timelines and inconsistent documentation standards.
Our analytical laboratory operates a fully qualified instrument fleet across chromatography, spectroscopy, dissolution, and stability — supporting regulated-market analytical work end-to-end:
Airis operates under a risk-based Quality Management System purpose-built for cGLP analytical services. The QMS spans qualifications and validations, change management, training, document control, customer complaints, OOS/OOT investigations, CAPA, and outsourced-activity audits — designed to deliver compliance that holds up under regulator scrutiny.
The Analytical Quality Assurance (AQA) unit — engineered to clear regulator review with minimum cycles.
Airis operates a fully risk-based Quality Management System designed to deliver high-quality cGLP services and operate in compliance with all applicable regulations. Every dossier is engineered to clear regulator review with minimum cycles.
Differentiated complex generics across CNS, immunology, oncology, fertility, neurology, and NTI categories — high-barrier dossiers built for niche segments where IP, BE rigor, and regulatory track record protect long-term value.
| Asset | Therapeutic Category | Dosage / Complexity | Status |
|---|---|---|---|
|
Mycophenolic Acid DR Tablets
180 / 360 mg
|
Immunosuppressant · Transplant / Nephrology | Modified-release immunosuppressant, highly variable molecule, BE challenge. | ANDA Approved |
|
Sertraline Capsules
|
CNS · Antidepressant (SSRI) | High-dose CNS. | Under FDA Review |
|
Clomiphene Citrate
|
Fertility · Gynecology | Oral tablet, fertility, long half-life, BE challenge. | ANDA Approved |
|
Mycophenolate Mofetil Powder for Suspension
|
Immunosuppressant · Transplant | Liquid immunosuppressant. | ANDA Approved |
|
Glycopyrrolate Oral Solution
|
Gastrointestinal · Anticholinergic (also pediatric use) | Liquid, pediatric-friendly. | ANDA Approved |
|
Guanfacine Tablets
|
CNS · ADHD / Antihypertensive | CNS, low-dose. | ANDA Approved |
|
Nimodipine Oral Solution Pre-Filled Syringe
|
Cardiovascular / Neurology · Cerebral vasospasm | Neuro, hospital-based. | Para IV Filing |
|
Nelarabine Injection
|
Oncology · Hematologic malignancies | Oncology, injectable. | ANDA Approved |
|
Valganciclovir Oral Solution
|
Antiviral · Infectious Disease / Transplant | Antiviral, pediatric liquid. | Para IV Filing |
| Molecule | Therapeutic Category | Dosage Form / Strength / Notes | Stage |
|---|---|---|---|
|
Solifenacin Succinate Tablets
|
Urology · Overactive bladder | Oral tablet | Development Completed |
|
Vancomycin Hydrochloride Capsules
|
Anti-infective · Antibiotic (GI infections) | Oral capsule | Development Completed |
|
Acyclovir Ointment
|
Antiviral · Dermatology | Topical semi-solid | Development Completed |
|
Aminocaproic Acid Tablets
|
Hematology · Antifibrinolytic | Oral tablet | Development Completed |
|
Nimodipine Oral Solution (PFS)
|
Cardiovascular / Neurology | Pre-filled syringe · neuro / hospital | Development Completed |
|
Mycophenolic Acid DR Tablets
|
Immunosuppressant | 180 mg / 360 mg · modified-release | Development Completed |
|
Glycopyrrolate Oral Solution
|
Gastrointestinal · Anticholinergic | 1 mg/5 mL (0.2 mg/mL) · pediatric | Development Completed |
|
Norepinephrine Bitartrate Injection
|
Critical Care / Cardiovascular · Vasopressor | 4 mg/4 mL (1 mg/mL) | Development Completed |
|
Nelarabine Injection
|
Oncology | 250 mg/50 mL (5 mg/mL) | Development Completed |
|
Oseltamivir Phosphate
|
Antiviral · Influenza | Oral suspension | Development Completed |
|
Sertraline HCl Capsules
|
CNS · Antidepressant | 150 mg & 200 mg | Development Completed |
|
Mesalamine DR Tablets
|
Gastrointestinal · IBD (Ulcerative colitis) | 1200 mg · modified-release · pivotal BE indicative | Development Completed |
|
Mesalamine DR Tablets
|
Gastrointestinal · IBD (Ulcerative colitis) | 800 mg · modified-release · pilot BE indicative | Development Completed |
|
Cariprazine Capsules
|
CNS · Antipsychotic | 1.5–6 mg · multi-strength | Development Completed |
|
Dalfampridine ER Tablets
|
CNS · Multiple sclerosis | 10 mg · extended-release | Development Completed |
|
Fosfomycin Tromethamine Granules
|
Anti-infective · Antibiotic (UTI) | 3 g · oral granules | Development Completed |
|
Itraconazole Oral Solution
|
Antifungal · Infectious Disease | 10 mg/mL · oral solution | Development Completed |
|
Lamotrigine ODT
|
CNS · Antiepileptic / Mood stabilizer | 25–200 mg · orally disintegrating tablet | Development Completed |
|
Loperamide HCl Capsules
|
Gastrointestinal · Antidiarrheal | 2 mg · oral capsule | Development Completed |
|
Doxylamine + Pyridoxine DR Tablets
|
Gynecology · Pregnancy nausea / vomiting | 10 mg / 10 mg · delayed-release combination | Development Completed |
Beyond the existing portfolio, Airis is actively originating complex, value-added generics — purpose-built for dossier developers and B2B platforms pursuing first-to-market positioning, franchise lifecycle extension, and differentiated technology across regulated and ROW markets.
First-wave generic launches engineered for Day-1 dossier filing at LOE.
Assets where BE confidence and analytical robustness are the entry barrier.
API behavior, polymer matrix, and dissolution profiling — inseparable by design.
VAMs layered onto anchor-molecule tablet/capsule franchises — underserved across EU and ROW.
Creams, ointments, and gels where IVRT and topical BE define the competitive set.
Sterile and non-sterile injectables — high-margin, low-competition hospital channel.
Tier-1 API integration and second-source DMF strategy as the market-entry lever.
Fixed-dose combinations engineered from inception around anchor molecules.
The true value of a pharmaceutical franchise lies in systematic expansion. Airis takes ownership of second- and third-wave dossiers — fixed-dose combinations, dosage-form variants, and strength extensions — delivering analytical efficiency, BE confidence, and predictable economics.
Airis serves as the R&D execution partner for leading BioPharma developers — running complex generic programs end-to-end, from molecule selection through regulator-cleared dossier. The relationships are long-running, the work is repeat business, and the dossiers stand up to USFDA, MHRA, and Health Canada review.
Across the last several years, Airis has served as the formulation and analytical R&D backbone for some of the most respected names in generic pharmaceuticals. We don't position ourselves as a vendor — we operate as the embedded R&D function for partners who choose to outsource the hardest part of their pipeline to a team that owns the science end-to-end.
These are co-development relationships, not transactional ones. Our partners come back program after program because the work is delivered cleanly: methods that hold up at validation, BE strategies that hold up in front of FDA, and dossiers that don't bounce.
Co-development is a long game. The partners who choose Airis stay because the work compounds — methods, analytical platforms, and franchise learnings travel with the relationship across every subsequent program.
From molecule selection and IP positioning through API sourcing, formulation, analytical method science, and dossier filing — one team, one accountable thread. Partners don't manage hand-offs.
Deep operational experience filing into USFDA, MHRA, Health Canada, and emerging markets — with a track record of regulator-quiet approvals on the first review cycle. Our partners' dossiers hold up under scrutiny.
Methods, platforms, and learnings travel with the partner across their portfolio. The first program is execution; every program after is leveraged from accumulated franchise knowledge.
In parallel with our partner programs, Airis is actively originating a pipeline of high-barrier complex generics for licensure to dossier developers and B2B platforms. Co-development partners get the embedded R&D function. License partners get a finished, regulator-ready dossier with a pre-qualified manufacturing path attached.
For BD, licensing, or technical due diligence enquiries — reach out directly. We respond to all qualified partnership enquiries within two business days.
Licensing, partnership models, franchise-led growth opportunities
Audits, due diligence, regulatory documentation requests
Plot No. 64 & 65, Road No. 5
ALEAP Industrial Estate
Gajularamaram, Quthubullapur Mandal
Hyderabad, Telangana 500090
India
FEI: 3012071812 · DUNS: 650864775
USFDA validity: 31 December 2026