Pharmaffiliates
Pharmaffiliates is an India-based pharmaceutical research organization founded in 2001 that manufactures impurity reference standards and provides CRDMO services including custom synthesis, analytical testing, and regulatory submissions to pharma, biotech, and research customers worldwide.
- Company typePrivate
- Founded2001
- HeadquartersHaryana, India
- Headcount251–500
- GTM typeB2B
- OfferingHardware or Manufacturing
What Pharmaffiliates does
Pharmaffiliates is a privately held India-headquartered research organization founded in 2001 that operates two integrated businesses: a pharmaceutical reference standards catalog operation and a full-service Contract Research, Development, and Manufacturing Organization (CRDMO). Its reference standards business maintains over 10,000 ready in-stock impurity standards and a 300,000+ compound catalog covering pharmaceutical, food and beverage, agro-chemical, environmental, and green chemistry applications, including deuterated and stable isotope-labeled compounds. Its CRDMO business delivers custom synthesis of small and large molecules, analytical method development and validation, stability studies per ICH guidelines, structure elucidation using advanced instrumentation (UPLC, 1D/2D NMR, LC-MS, ICP-MS), impurity profiling, polymorphism studies, nano-lipoidal novel drug delivery systems, regulatory consulting, DMF and ANDA dossier preparation, GMP/GLP training, and third-party audits for EMEA compliance. The company holds USFDA-inspected status and commits to an ISO/IEC 17025:2017-aligned quality system.
Pharmaffiliates firmographics
Firmographics- Name
- Pharmaffiliates
- Legal name
- Pharmaffiliates Private Limited
- Website
- https://pharmaffiliates.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- Pharmaffiliates is an India-based pharmaceutical research organization founded in 2001 that manufactures impurity reference standards and provides CRDMO services including custom synthesis, analytical testing, and regulatory submissions to pharma, biotech, and research customers worldwide.
- Ownership category
- akta.pro rank
Pharmaffiliates industry classification
Industry- Product category
- Pharmaceutical Reference Standards
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Drugs and Druggists' Sundries Merchant Wholesalers (424210)
- SIC
- Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834), Chemicals & Allied Products (2800)
- akta.pro primary industry
- Impurity / Reference Standard Synthesis & Characterization (HLAGAHAG)
- akta.pro secondary industries
- Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ), Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)
Keywords
Where Pharmaffiliates is headquartered
LocationHeadquarters
- HQ city
- Haryana
- HQ country
- India
- HQ region
- Asia
Offices6 records
Markets served
Pharmaffiliates business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Infrastructure, Operations, Supply Chain, Marketing or Sales
Revenue model
- Pharmaceutical Reference Standards Sales: Sale of pharmaceutical impurity standards, reference standards, metabolites, stable isotopes, and related compounds to pharmaceutical companies, API manufacturers, and research institutions. Products are sold in catalog quantities with custom synthesis available.
- Contract Research Services: Custom synthesis services for small and large molecules, analytical method development and validation, stability studies, and regulatory consulting including DMF/ANDA submissions. Charged on project or FTE (Full-time Equivalent) basis.
- Analytical Testing Services: Wet lab analysis, instrumentation analysis, and specialized testing services for pharmaceutical products. Services include structure elucidation, purity assessment, and regulatory-compliant testing.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Standard catalog products |
| Other | Multi-year contract | Custom synthesis services |
| Other | Multi-year contract | FTE-based projects |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels5 records
Pharmaffiliates product offering
Product offeringCore offering
Pharmaffiliates manufactures pharmaceutical impurity reference standards (over 10,000 in-stock items, 300,000+ catalog compounds) and provides Contract Research, Development, and Manufacturing Organization (CRDMO) services including custom synthesis of small and large molecules, deuterated compounds, analytical method development and validation, stability studies, structure elucidation, impurity profiling, regulatory dossier/DMF/ANDA submission support, and GMP/GLP training and third-party audits for pharma, biotech, API manufacturers, CROs, and academic research customers globally.
Product overview
Pharmaffiliates is a research-driven CRDMO (Contract Research, Development, and Manufacturing Organization) and impurity standard manufacturer based in India. The company operates two primary business segments: a comprehensive portfolio of pharmaceutical, food, environmental, and agrochemical reference standards, and full-service contract research capabilities spanning drug development from early research through regulatory submission. The core product offering includes over 10,000 ready-in-stock impurities and 300,000+ compounds in catalog, supported by integrated services including custom synthesis (small and large molecules), analytical method development and validation, stability studies, structure elucidation, regulatory consulting, DMF/ANDA submissions, and GMP/GLP training. The company maintains global operations with offices in India, UK, Canada, and Lithuania, and is USFDA inspected.
Differentiator
Problem solved
Functional benefit
Products and services
- Pharmaceutical Reference Standards Certified reference standards for pharmaceutical quality control and testing, including impurities, metabolites, intermediates, glucuronides, nitrosamines, peptides, stable isotopes, psychotropic substance standards, food and beverage standards, agro-chemical standards, environmental standards, green chemistry standards, and fine chemicals, sold to API manufacturers, finished-dose pharma companies, biotech firms, CROs, and research institutions.
- Ultrachrome Chromatography Columns Proprietary branded chromatography columns for analytical separations, sold alongside the reference standards catalog to pharmaceutical and analytical laboratory customers.
- Deuterated and Isotope-Labeled Compounds Catalog and custom-synthesized deuterium, 13C, 15N, 31P, 19F, and 17O isotope-labeled compounds used for reaction mechanism studies, metabolic pathway analysis, and as mass spectroscopy internal standards.
- CRDMO Services Integrated Contract Research, Development, and Manufacturing Organization services encompassing the full drug development lifecycle from early research through commercialization, including custom synthesis, analytical development, regulatory submission support, and manufacturing, provided under one roof to pharmaceutical and biotech customers.
- Custom Synthesis (Small and Large Molecules) Custom synthesis of small molecules (APIs, key intermediates, chiral standards, metabolites, glucuronides, stable isotopes from milligrams to grams) and large/complex biomolecules requiring multi-step synthesis, delivered to pharmaceutical and biotech clients.
- Novel Drug Delivery Systems Development of nano lipoidal carrier systems using bio-friendly biomaterials such as phospholipids for applications in dermatology, cosmetics, and nutraceuticals, provided to pharmaceutical and personal care clients.
- Impurity Profiling Identification, isolation, and characterization of pharmaceutical impurities for safety evaluation and regulatory compliance, delivered to API manufacturers and finished-dose pharmaceutical companies.
- Polymorphism Studies Study of crystalline forms using vibrational spectroscopies (IR and Raman) to detect and characterize different polymorphic forms of drug substances for pharmaceutical development clients.
- Analytical Method Services (Development, Validation, Transfer) Analytical method development for APIs and formulations testing for specificity, linearity, accuracy, precision, and robustness; validation of analytical procedures for API, drug products, and containers per regulatory requirements; and formal transfer of validated methods between laboratories.
- Stability Studies and Evaluation Stability testing including R&D preliminary studies, QC stability studies, comparator studies, and photostability evaluations per ICH Q1A–Q1F guidelines, delivered to pharmaceutical development and quality clients.
- Structure Elucidation and Evaluation Structural characterization using UPLC, chiral chromatography, and 1D/2D NMR for intermediates, impurities, degradation products, and metabolites, delivered to pharmaceutical and biotech customers.
- Regulatory Consulting Expert consulting for global regulatory issues with a focus on flexibility, multidisciplinary projects, and relations with health authorities, provided to pharmaceutical, biotech, and API manufacturer clients.
- Dossier Preparation (CTD Format) Preparation of regulatory dossiers and ANDAs in Common Technical Document (CTD) format for global submissions, delivered to pharmaceutical manufacturers and biotech firms.
- DMF and ANDA Submissions Preparation of Drug Master File (DMF) and Active Substance Master File (ASMF) with CMC regulatory documentation for FDA, EMA, and worldwide submissions, delivered to API manufacturers and finished-dose pharmaceutical companies.
- Analytical Testing Services (Wet Lab, Instrumentation, Specialized) Classical wet chemistry techniques (loss on drying, limit tests, identification, TLC, sulphated ash, viscosity) and instrument-based analytical testing using UV, GC-MS, HPLC, UPLC, FTIR, ICP, and ICP-MS, plus unique specialized testing for complex requirements, delivered to pharmaceutical, biotech, and research customers.
- GMP/GLP Training Programs Expert-led training programs including lectures, workshops, and videos covering GMP and GLP topics, delivered to pharmaceutical professionals across the industry.
- Third-Party Audits Independent third-party auditing services in India and neighboring countries per EMEA requirements, delivered to pharmaceutical manufacturers seeking inspection readiness.
- FTE-Based Research Projects Full-time equivalent (FTE) based project services with dedicated research teams headed by Ph.D. scientists, providing outsourced pharmaceutical R&D capacity to clients.
Quantifiable outcome
- Supports regulatory compliance in 90+ countries
- +2 more outcomes
Companies that use Pharmaffiliates
Customer profileSegments5 records
Ideal customer profiles3 records
Pharmaffiliates technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Pharmaffiliates partnerships and signals
Strategic signalScale indicators7 records
Recent moves4 records
Expansion highlights5 records
Pharmaffiliates competitors and assessment
Company assessmentDirect peers
- Clearsynth Labs: Clearsynth is an India-based manufacturer of impurity reference standards, stable-isotope-labeled compounds, and CRDMO services — directly competing with Pharmaffiliates in catalog SKU overlap and a near-identical go-to-market targeting global generic pharma and CRO customers.
- Toronto Research Chemicals: TRC is a leading global supplier of impurity reference standards and deuterated compounds serving pharmaceutical and analytical customers — the closest catalog-direct competitor to Pharmaffiliates' reference standards and isotope-labeled portfolios.
- LGC Standards: LGC is one of the largest global reference-material producers (pharmaceutical impurities, CRMs, calibration standards) and operates adjacent CRMO capabilities — a direct competitor in impurity standards with overlap into analytical services.
- TCI Chemicals: TCI manufactures and globally distributes organic chemicals, reference standards, and stable-isotope-labeled reagents — directly comparable in catalog breadth, regulatory-grade quality, and pharma customer base.
Broad incumbents
- Sigma-Aldrich (MilliporeSigma / Merck KGaA): MilliporeSigma/Supelco is the dominant global reference-standards supplier covering impurities, analytical standards, CRMs, and chromatography alongside a vast life-sciences portfolio — the broad incumbent whose catalog Pharmaffiliates competes against.
- Syngene International: Syngene is an Indian-headquartered integrated CRDMO offering discovery, development, and manufacturing services to global pharma and biotech — comparable in geography, service breadth, and target buyer but at a meaningfully larger scale.
- Piramal Pharma Solutions: Piramal operates a global CDMO with API and drug-product manufacturing plus analytical/regulatory services — a fellow Indian-rooted CRDMO that overlaps with Pharmaffiliates on the development-and-submission workstream, but at materially larger scale.
- Eurofins Scientific: Eurofins is a global contract testing, reference-material, and analytical services group — comparable to Pharmaffiliates' analytical testing and reference-standards offerings as part of a much broader life-sciences testing portfolio.
Emerging players
- Aragen Life Sciences (GVK Biosciences): Aragen is an India-based CRDMO with discovery, development, and CMC services — overlapping with Pharmaffiliates on impurity profiling, analytical, and regulatory services for pharma R&D customers.
- Vivimed Labs: Vivimed manufactures specialty chemicals and pharma intermediates including reference standards and intermediates — comparable product overlap to Pharmaffiliates' catalog and custom-synthesis business from a fellow Indian specialty-chemicals platform.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
Pharmaffiliates social profiles
Digital presencePharmaffiliates compliance and trust
Trust signalCompliance2 records
Pharmaffiliates financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pharmaffiliates leadership team
Management profileNumber of profiles
Profiles1 record
Pharmaffiliates funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pharmaffiliates 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 Pharmaffiliates
What does Pharmaffiliates do?
Pharmaffiliates manufactures pharmaceutical impurity reference standards (over 10,000 in-stock items, 300,000+ catalog compounds) and provides Contract Research, Development, and Manufacturing Organization (CRDMO) services including custom synthesis of small and large molecules, deuterated compounds, analytical method development and validation, stability studies, structure elucidation, impurity profiling, regulatory dossier/DMF/ANDA submission support, and GMP/GLP training and third-party audits for pharma, biotech, API manufacturers, CROs, and academic research customers globally.
Is Pharmaffiliates a public or private company?
Pharmaffiliates is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Pharmaffiliates founded?
Pharmaffiliates was founded in 2001. It employs 251 to 500 people.
Where is Pharmaffiliates based?
Pharmaffiliates is headquartered in Haryana, India, in the Asia region.
How does Pharmaffiliates make money?
Three revenue lines are on record. Pharmaceutical Reference Standards Sales are the primary driver. The others are contract Research Services and analytical Testing Services.
Who are Pharmaffiliates's main competitors?
Direct peers on record are Clearsynth Labs, Toronto Research Chemicals, LGC Standards and TCI Chemicals. Broad incumbents are Sigma-Aldrich (MilliporeSigma / Merck KGaA), Syngene International, Piramal Pharma Solutions and Eurofins Scientific. Emerging players are Aragen Life Sciences (GVK Biosciences) and Vivimed Labs.
Does Pharmaffiliates have an API?
No public API is recorded for Pharmaffiliates.
What industry is Pharmaffiliates in?
Pharmaffiliates's product category is Pharmaceutical Reference Standards. Its primary akta.pro industry code is HLAGAHAG, Impurity / Reference Standard Synthesis & Characterization, with a secondary code of HLAGAHAM, Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC). Its NAICS code is 325412 and its SIC code is 8731.