NABL CDSCO USFDA Inspected — Manesar & Bangalore NDA · Confidential

Deformulation and Reverse Engineering | Pharma and Consumer Products | Auriga Research

NABL-accredited quantitative deformulation of pharmaceutical dosage forms and consumer / cosmetic / personal-care products — HPLC, LC-MS/MS, FTIR, TGA and NMR under a signed NDA. Used by generic developers, CDMOs, D2C brands and brand owners.

Two Use Cases — One Analytical Platform

  • · Pharmaceutical deformulation — reverse engineering of tablets, capsules, oral liquids, topicals and sterile products for generic developers (RLD characterisation under Bolar / Section 107A), CDMOs and innovator R&D teams
  • · Consumer & cosmetic deformulation — benchmarking of skincare, haircare, colour cosmetics, personal-care formulations and nutraceuticals against market-leading references for D2C brands and consumer-goods companies
  • Every engagement is covered by a signed NDA before competitor samples are accepted into YLIMS. Engagement statement also confirms lawful purpose under IP and contractual constraints.

Deformulation is the scientific analysis of a finished product to reveal its ingredients, formulation strategy and manufacturing characteristics. Reverse engineering extends that analysis to benchmark competitor products, evaluate product claims, support formulation transfer and determine how a product achieves its performance profile. Auriga Research delivers deformulation across both regulated pharmaceutical dosage forms and consumer / cosmetic / personal-care products from one NABL-accredited lab network with a single SPOC and a single confidentiality scope.

On the pharma side, our workflow covers material identification, quantitative assay by HPLC and UPLC, impurity screening per ICH Q3A(R2)/Q3B(R2), residual solvent screening per ICH Q3C(R8), elemental impurity testing per ICH Q3D(R2), polymer and coating analysis by FTIR and TGA, NMR structural confirmation of identified APIs and USP <711> dissolution-performance benchmarking against the reference listed drug. On the cosmetics and consumer side we cover skincare, haircare, colour-cosmetics, personal-care and nutraceutical deformulation with the same instrument platform — quantitative excipient and active identification, polymer analysis and competitor-overlay benchmarking. The 9,226-reference-standard inventory accelerates excipient identification work that would otherwise require external standard sourcing.

Whether you are developing a generic pharmaceutical, characterising a competitor cosmetic for a market-entry decision, or evaluating a consumer healthcare product, our deformulation services provide the factual data you need to make confident development and commercial decisions — delivered under a signed NDA and within an engagement statement that confirms the lawful purpose of the work.

Deformulation & Reverse Engineering Services

Each service mapped to its analytical technique and use case so pharma, CDMO and consumer-brand teams can scope at a glance.

Excipient

Quantitative Excipient Identification

Quantitative excipient identification by HPLC and LC-MS/MS — backed by Auriga’s 9,226-reference-standard inventory for unambiguous matching across IP, USP, EP and BP monograph excipients.

API

API Identification & Quantification

API identification and quantification by HPLC, UPLC and NMR — orthogonal techniques for structural confirmation and assay of the active in the finished dosage form.

Polymer

Polymer & Coating Analysis

Polymer and coating analysis by FTIR (3 labs) and TGA (Manesar) — film-coating composition, controlled-release polymers, capsule shells and packaging-contact materials.

Generic

Reverse Engineering for Generics

Reverse engineering for generic drug development — RLD characterisation, formulation gap analysis and bioequivalence-relevant attribute mapping under Bolar / Section 107A exemptions.

Consumer

Competitor Benchmarking — Consumer & Cosmetics

Competitor product benchmarking for consumer goods and cosmetics — skincare, haircare, colour cosmetics, personal care and nutraceuticals deformulated against the market leader.

Report

Full Formulation Report

Full formulation report for regulatory dossier or R&D — ingredient list, percentage composition (where assay methods are feasible), manufacturing-critical attributes and benchmarking section.

How It Works — 4 Steps to Your NABL Deformulation Report

1

Get a Quote

Share product type (pharma, cosmetic or consumer) and objective (generic development, benchmarking or counterfeit investigation). Confirm NDA requirements before submitting competitor samples. Your SPOC scopes analytical battery and TAT.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody — and locked behind the NDA scope agreed at quote stage.

3

Testing and QA Review

Tested under NABL-accredited conditions across HPLC, LC-MS/MS, FTIR, TGA, ICP-MS and NMR as required by the deformulation scope. Results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for CDSCO, USFDA and regulatory submission. Track via YLIMS. Raw chromatograms and spectra supplied on request.

Project Timelines

Package Turnaround Time
Standard Deformulation Report 10-15 business days
Rush Investigation 5-7 business days
Profile Comparison & Benchmarking (vs RLD or innovator) 10-14 business days
Cosmetic / Consumer Competitor Benchmarking 10-14 business days
Formulation Recreation Support 2-4 weeks

Who Needs Deformulation & Reverse Engineering

  • ✓ Generic developers requiring quantitative formulation analysis of reference listed drugs (RLDs)
  • ✓ CDMO clients needing competitor product analysis before formulation development and tech transfer
  • ✓ Cosmetics and personal-care brands benchmarking market-leading skincare, haircare and colour-cosmetic products
  • ✓ Brand owners investigating counterfeit products and supply-chain dilution
  • ✓ Pharmaceutical innovators troubleshooting performance failures or formulation drift
  • ✓ Consumer healthcare D2C brands characterising competitor nutraceutical and supplement formulations
  • ✓ M&A and post-acquisition teams characterising acquired product portfolios
  • ✓ Regulatory affairs teams compiling dossier evidence for product equivalence claims

Why Auriga for Deformulation

Complete Analytical Platform — HPLC + LC-MS/MS + FTIR + TGA

HPLC and UPLC (110+ systems, 605 columns), LC-MS/MS (9 systems), FTIR (3 labs), TGA (Manesar), GC-MS, ICP-MS (5 systems) and NMR — every excipient and polymer class covered without external instrument hand-offs.

Signed NDA Before Sample Receipt

Every deformulation engagement is covered by a signed confidentiality agreement before competitor or innovator samples are accepted into YLIMS. Engagement statement also confirms lawful purpose of the work.

9,226 Reference Standards In-House

Auriga’s 9,226 active reference standards accelerate excipient and API identification work — matches that would otherwise require weeks of external standard sourcing happen in days.

Pharma + Cosmetics Under One NABL Report

Same lab network handles regulated pharma dosage forms AND consumer / cosmetic / personal-care deformulation — single SPOC, single quality system, cross-referenced to the Cosmetics Testing scope.

USFDA Inspected — Manesar & Bangalore

Deformulation data generated at USFDA Inspected facilities is accepted in regulatory dossiers without re-testing — useful for generic developers preparing ANDA-grade RLD characterisation.

Current ICH Revisions Cited

Reports cite the current ICH revisions — Q2(R2) for analytical procedure validation, Q3C(R8) for residual solvents and Q3D(R2) for elemental impurities — so deformulation evidence stays submission-ready.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

Related Testing Services

Impurity Profiling Cosmetics Testing Method Development & Validation Excipient Testing NABL Accredited Lab All Pharma Testing →

Frequently Asked Questions — Deformulation & Reverse Engineering

What is deformulation and reverse engineering for pharmaceutical and consumer products?
Deformulation and reverse engineering is the analytical process of identifying the composition, formulation and manufacturing attributes of a finished pharmaceutical, cosmetic or consumer product. It includes quantitative excipient identification, API quantification, polymer and coating analysis, dosage form performance testing and full formulation report generation. Auriga covers both regulated pharmaceutical dosage forms (tablets, capsules, oral liquids, topicals, sterile products) and consumer goods (cosmetics, skincare, haircare, personal care, nutraceuticals and dietary supplements).
Does Auriga deformulate cosmetics and consumer personal-care products?
Yes. Cosmetics and consumer-product deformulation is a core use case for the Auriga reverse-engineering programme — not a side service. Skincare, haircare, colour cosmetics, personal-care formulations and consumer healthcare products are routinely deformulated for D2C brands, multinational consumer goods companies and CDSCO-registered cosmetic importers. Typical work includes competitor benchmarking against market-leading products, claims troubleshooting, counterfeit investigation and gap analysis against innovator references — all under a signed NDA, with reports cross-referenced to Auriga’s cosmetics testing scope at [Cosmetics Testing](/testing/cosmetics-testing/).
Which analytical techniques does Auriga use for deformulation?
Deformulation projects draw on the full Auriga analytical platform — HPLC and UPLC for assay and impurity profiling, LC-MS/MS (9 systems) for trace excipient and impurity identification, GC-MS for volatile organics and residual solvents per ICH Q3C(R8), FTIR (3 labs) for polymer and coating identification, TGA at Manesar for thermal decomposition and moisture, ICP-MS (5 systems) for elemental impurities per ICH Q3D(R2), NMR for structural confirmation of identified APIs, and USP <711> dissolution for performance testing. The 9,226 reference standard inventory accelerates excipient identification work that would otherwise require external sourcing.
Is reverse engineering legal and appropriate for product development?
Yes, reverse engineering is a legitimate analytical tool when used ethically and within intellectual property boundaries. Auriga Research focuses on quality assessment, competitor benchmarking, formulation troubleshooting, generic-drug development under Bolar / Section 107A exemptions and regulatory support while respecting patents, copyrights and contractual agreements. Every deformulation engagement is covered by a signed NDA before samples are accepted, and clients sign an engagement statement confirming the lawful purpose of the work.
How quickly can you deliver deformulation results?
Standard deformulation projects are typically completed in 10-15 business days depending on product complexity, dosage form and analytical scope. Rush investigations close in 5-7 business days. Profile comparison and benchmarking against innovator or competitor references runs in 10-14 business days, and full formulation recreation support spans 2-4 weeks. Fast-track options are available for urgent formulation troubleshooting or market entry support, subject to sample availability and testing package requirements.
What deliverables are included in a deformulation report?
Every deformulation engagement closes with a structured technical report covering: (1) executive summary of identified ingredients and proposed formulation; (2) qualitative identification of all APIs, excipients and functional additives (with confidence indicators and supporting spectra / chromatograms); (3) quantitative composition where assay methods are feasible (HPLC/UPLC, LC-MS/MS, GC, ICP-MS, KF); (4) physical characterisation data — particle size, density, dissolution profile, hardness, friability as applicable to the dosage form; (5) impurity, residual solvent (Q3C(R8)) and elemental (Q3D(R2)) profile; (6) benchmarking against the innovator or reference product when one is supplied; (7) interpretation notes and recommended next-step studies. Reports are issued as a signed PDF; raw chromatograms, spectra and instrument printouts are supplied on request and retained per our ISO/IEC 17025:2017 quality system.
What is the minimum sample quantity required for a deformulation project?
Required sample quantity depends on the dosage form and depth of the investigation. As general guidance: solid oral (tablets/capsules) — 20 to 30 intact units (≈ 10-20 g of formulation) for a standard package including ID, assay, dissolution and physical characterisation; oral liquids and syrups — 50 to 100 mL across at least two intact units; topicals (creams, ointments, gels) — 30 to 50 g across two units; sterile injectables — at least 10 vials/ampoules for ID, assay and physical-chemical work-up; cosmetics and personal care — 50 to 100 g/mL across two unopened retail units to permit triplicate analysis plus reserve. For formulation recreation support or extended benchmarking, additional reserve quantity is recommended. Confirm exact quantity with our analytical team before despatch.
Does Auriga undertake deformulation of patent-protected products?
Auriga undertakes deformulation of patent-protected products only for legally permissible purposes — including, but not limited to: research-and-experimental-use exemptions (Bolar / Section 107A in India and equivalent provisions in other jurisdictions); patent-expiry generic development where work is scheduled to coincide with patent expiry; competitor benchmarking and quality assessment that does not result in commercialisation; freedom-to-operate analysis supporting patent-around design; and own-brand reverse engineering, post-acquisition or recall investigations. Clients are asked to sign an engagement statement confirming the lawful purpose of the work and to disclose any third-party IP or contractual constraints. Auriga does not undertake deformulation engagements intended to enable infringing commercial manufacture during the active patent term, and we will decline or withdraw from any engagement where the purpose is unclear or appears infringing. All client data, samples and deformulation outputs are treated as confidential under an executed NDA.

Need Deformulation or Reverse Engineering Support?

NABL-accredited investigation and product benchmarking for pharmaceutical dosage forms and consumer / cosmetic / personal-care products. Every engagement under signed NDA.

+91-7428116100 Get a Quote
Call Now Get a Quote

Type to search services, tests, and locations…