Enaltec Labs

What Enaltec Labs does

Enaltec Labs Pvt. Ltd. is a privately held Indian pharmaceutical Contract Development and Manufacturing Organization (CDMO) founded in 2006 and headquartered in Navi Mumbai, Maharashtra. The company operates across three integrated service pillars: DSIR-approved API research and development, API manufacturing, and finished-dosage formulation development. Its manufacturing footprint comprises the US FDA-inspected (2013, 2015, 2019) Ambernath plant serving regulated markets and the WHO-GMP-certified Pithampur plant serving semi-regulated markets, with reactor capacity ranging from 50L to 5,000L and a dedicated high-containment unit for HPAPI/oncology products up to OEB4/OEL4. The company has filed 16 US DMFs, 2 CEPs, 2 EU DMFs, and holds 4 ANDA approvals, with 75+ FDF dossiers available for technology transfer.

Enaltec serves 125+ pharmaceutical clients across 50+ countries, including generic formulators, specialty pharmaceutical companies, and life-sciences firms targeting regulated (US, EU, Japan, Canada, Australia) and semi-regulated (Southeast Asia, Latin America, Russia) markets. Its technical capabilities span complex reactions including chiral chemistry, asymmetric oxidation/reduction, hydrogenations, enzymatic reactions, and high-pressure/cryogenic processing. The R&D team includes approximately 60 API scientists (4 PhDs, 20 M.Sc.) and 80 CDMO scientists, with 100+ years of combined leadership experience.

The company generates revenue through four business models: fee-for-service contract research with milestone-based billing; turnkey/co-development with profit-sharing on commercialized products; CMO/CDMO services for advanced intermediates and drug substances; and out-licensing of ANDA-approved products and FDF dossiers for technology transfer to non-US and European markets. GTM is primarily B2B enterprise sales to global generic pharmaceutical companies, supplemented by licensing partnerships. Quality systems are aligned to cGMP, ICH Q7, Schedule M, and Schedule L standards, with 21 CFR Part 11-compliant analytical infrastructure.

Name

Enaltec Labs

Legal name

Enaltec Labs Pvt. Ltd.

Website

https://enaltec.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Enaltec Labs is an Indian pharmaceutical CDMO founded in 2006 that provides API research, API manufacturing, and formulation development services to 125+ generic pharmaceutical clients across 50+ countries, leveraging US FDA-inspected and WHO-GMP-certified facilities for regulated and semi-regulated markets.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Development and Manufacturing (CDMO)

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834), Services-Testing Laboratories (8734)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule API & Intermediates CDMO (HLAGABAA), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Pharmaceutical CDMO services
• API manufacturing
• Active pharmaceutical ingredients
• Formulation development
• Contract research manufacturing

Headquarters

HQ city

Mumbai

HQ country

India

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Fee-for-Service Contract Research: Client agrees to project cost under agreed scope of work with milestones paid on achievement of deliverables. Project completes after technology transfer to client's manufacturing site and/or successful Bioequivalence studies.
2. Turnkey/Co-development/Profit Sharing: Enaltec provides financial contribution to projects with profits split after product launch in ratio of investment. Includes backward integrated projects with API of interest.
3. API Manufacturing CMO Services: Technology transfer and manufacturing of advanced intermediates and drug substances for pre-clinical/clinical supplies, formulation trials, and new product launches
4. Product Licensing: Out-licensing of 4 ANDA approved products for non-US markets plus 75+ FDF dossiers for technology transfer to regulated markets (Europe with eCTD compliance)

Go-to-market motion3 records

Distribution channels3 records

Marketing channels3 records

Core offering

Enaltec Labs is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) providing API research, API manufacturing, and formulation development services to global generic pharmaceutical companies. The company offers fee-for-service contract research, turnkey/co-development, profit-sharing, and licensing arrangements, supported by two manufacturing plants (US FDA-inspected Ambernath and WHO-GMP certified Pithampur) and a DSIR-approved R&D center. Its offerings include 4 ANDA-approved products and 75+ FDF dossiers available for technology transfer to regulated and semi-regulated markets.

Product overview

Enaltec Labs operates as a Contract Development and Manufacturing Organization (CDMO) with three core service pillars: API Research, API Manufacturing, and Formulation Development. The API Research services (DSIR-approved R&D center) support synthesis and process development for technologically intensive APIs. The manufacturing division operates two plants—the US FDA-approved Ambernath facility serving regulated markets and the WHO-GMP certified Pithampur plant for semi-regulated markets. The Formulation Development arm offers comprehensive contract R&D services across oral solids, liquids, dermatology, injectables, and oncology products through various business models including fee-for-service, co-development, and licensing. The company also offers 4 ANDA-approved products and 75+ FDF dossiers available for technology transfer, along with specialized analytical, regulatory affairs, and intellectual property management services.

Differentiator

Problem solved

Functional benefit

Products and services

• API Research (R&D) Services DSIR-approved contract research services for Active Pharmaceutical Ingredients including synthesis, process development, and analytical research targeting complex, technologically intensive APIs for niche global markets. Service supports 90+ products developed over 16 years.
• API Manufacturing Services Contract manufacturing and supply of Active Pharmaceutical Ingredients (APIs) for regulated and semi-regulated markets, supported by two multipurpose plants with reactor capacities from 50L to 5,000L and capabilities including cryogenic, high-pressure, and pyrophoric reactions.
• CMO Services (Advanced Intermediates and Drug Substances)
• Contract Research and Development (Formulation)
• Oncology Development and Manufacturing
• Analytical Development Services
• Licensing (ANDA Products and FDF Dossiers)
• Intellectual Property Management Services
• Regulatory Affairs Services

Quantifiable outcome

• 90+ products developed in 16 years
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators12 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Syngene International: Largest Indian CRDMO; provides API development, formulation, and analytical services to innovator and generic pharma; broader and more discovery-focused, but overlaps on API CDMO.
• Aurobindo Pharma: Vertically integrated Indian generics giant with large API and formulation operations; serves the same global generic customers with overlapping complex-API capabilities, though at much larger scale.
• Jubilant Pharmova (Jubilant Biosys / CDMO): Indian CDMO with sterile fill-finish, API, and formulation services; larger and more diversified but competes for the same regulated-market generic pharma customers.
• Piramal Pharma Solutions: Large Indian CDMO offering integrated API, formulation, and analytical services globally — broader portfolio but overlaps Enaltec on complex API development and HPAPI/oncology handling.

Regional players

• Granules India: Indian API and finished dosage manufacturer serving global generics; overlap in formulation development and regulated-market supply, with a more formulation-heavy mix than Enaltec.

Direct peers

• Suven Pharma: Indian API and CRAMS company focused on complex small molecules for global pharma — closely comparable on niche, technology-driven API positioning and customer mix.
• Sai Life Sciences: Indian CRDMO offering API process R&D, manufacturing, and formulation development for global pharma — comparable in integrated service model and complex-chemistry positioning.
• Divis Laboratories: Indian API manufacturer and CDMO with strengths in complex generics and custom synthesis for regulated markets — directly comparable on API manufacturing scale, US FDA compliance posture, and generic-pharma customer base.
• Laurus Labs: Indian API and formulation CDMO serving global generic and innovator pharma; comparable in API manufacturing, formulation development, and regulated-market filings (US DMFs, CEPs).
• Neuland Laboratories: Indian API and CDMO focused on complex small molecules and contract manufacturing for global generics — closely comparable in customer segment, scale, and regulatory profile.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance13 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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 →

Frequently asked questions about Enaltec Labs