What Steril-Gene does

Steril-Gene Life Sciences (P) Ltd. is an India-based pharmaceutical contract development and manufacturing organization (CDMO) founded in 2010 as a joint venture between Madras Pharmaceuticals (India) and Lloyd Laboratories (Philippines). The company operates a US FDA-approved greenfield manufacturing facility of approximately 81,000 sq.m (with ~40,000 sq.m built-up area) in Puducherry, India, organized into four specialized blocks: Sterile Block (Class A), Hormone Block, Potent Block, and General Oral Solid Block (Class D). It manufactures eight or more dosage forms including ampoules (1-10ml), vials (1-100ml) including lyophilized injectables, pre-filled syringes, ophthalmic vials, tablets, capsules, softgel capsules, and sachets, using globally sourced equipment from Tofflon, Serail, Steril Line Italy, ROTA Germany, Truking, Cadmach, ACG, and Parle.

The company's technology platform combines specialized containment capabilities — isolator technology for potent and hormonal API handling, bag-in/bag-out AHU systems, and dedicated lyophilization lines — with regulatory infrastructure including US FDA, EU GMP, MHRA, TGA, Health Canada, ANVISA, WHO GMP, MCAZ, TMDA, DIGIMED, and ISO certifications, enabling global market access across North America, Europe, South America, Africa, Australia, and Southeast Asia. R&D is supported by 15 formulation scientists and 30 analytical scientists, with additional dedicated teams of 20+ regulatory professionals and 15 technology transfer scientists. The facility's stated annual capacity is 3 billion tablets, 1 billion capsules, 45 million vials, 13 million ampoules, 10 million pre-filled syringes, and 1.3 billion softgels.

Steril-Gene generates revenue through six primary service streams: (1) full-spectrum CDMO services including development, scale-up, and commercial manufacturing; (2) pure CMO services with per-batch or per-unit pricing; (3) technology transfer services; (4) site transfer services where Steril-Gene is added as a secondary manufacturing site; (5) in-licensing/out-licensing of ready-to-file products with dossier support; and (6) regulatory dossier preparation in CTD, ECTD, and ACTD formats. Pricing is quote-based and not publicly disclosed. The company employs 101-250 people, serves 100+ customers globally (disclosed names include Cipla and Marksans UK), and reports a portfolio of 560+ dosage forms. Go-to-market is direct enterprise B2B sales to pharmaceutical firms via business development outreach, with no intermediary distributors. The company is privately held with no venture capital, private equity, or public shareholders disclosed.

Name

Steril-Gene

Legal name

Steril-Gene Life Sciences (P) Ltd.

Website

https://steril-gene.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Steril-Gene Life Sciences is an India-based pharmaceutical CDMO operating a US FDA-approved 81,000 sq.m facility in Puducherry. It provides contract development, manufacturing, technology transfer, site transfer, and regulatory services across eight or more dosage forms to global pharmaceutical companies.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing & Development (CDMO)

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Contract pharmaceutical manufacturing
• Pharmaceutical CDMO services
• Sterile injectable manufacturing
• Technology transfer services
• Regulatory dossier preparation

Headquarters

HQ city

Chennai

HQ country

India

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Development and Manufacturing Services (CDMO): Full-service pharmaceutical development and manufacturing where Steril-Gene develops formulations and manufactures drug products for clients. Revenue generated through development fees, scale-up costs, exhibit batches, and ongoing manufacturing fees.
2. Contract Manufacturing Services (CMO): Pure manufacturing services for pharmaceutical products already developed. Revenue generated through per-batch or per-unit manufacturing fees.
3. Technology Transfer Services: Transfer of product technology from external organizations into Steril-Gene facility. Revenue from feasibility trials, scale-up, process optimization, and exhibit batch services.
4. Site Transfer Services: Adding Steril-Gene as secondary manufacturing site for existing approved products. Revenue from technical documentation, feasibility trials, scale-up, and regulatory support.
5. In-Licensing/Out-Licensing: Customer acquires rights to market Steril-Gene's ready-to-file products in chosen markets along with dossier documents for registration. Revenue from product licensing fees and ongoing manufacturing.
6. Regulatory Services: Preparation of regulatory dossiers in CTD, ECTD, and ACTD formats for product registrations across various countries. Revenue from regulatory service fees.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Steril-Gene is a pharmaceutical contract development and manufacturing organization (CDMO) operating a US FDA-approved, 81,000 sq.m greenfield manufacturing facility in Puducherry, India. It provides end-to-end services including formulation development, contract manufacturing across multiple dosage forms (injectables in ampoules, vials, prefilled syringes, ophthalmic vials, lyophilized injections, tablets, capsules, softgels, and sachets), technology transfer, site transfer, and regulatory dossier preparation for pharmaceutical firms worldwide. The facility is divided into four specialized manufacturing blocks (Sterile, Hormone, Potent, and General Oral Solid Block) supported by a separate R&D facility with 45 scientists.

Product overview

Steril-Gene Life Sciences is a US FDA-approved pharmaceutical contract development and manufacturing organization (CDMO) providing end-to-end solutions including Contract Development & Manufacturing (CDMO), Contract Manufacturing (CMO), Technology Transfer, Site Transfer, and Regulatory Services. The company manufactures a comprehensive portfolio of dosage forms across four specialized production blocks: Sterile Block (ampoules, vials, pre-filled syringes, ophthalmic vials), Hormone Block (hormonal tablets and softgel capsules), Potent Block (potent tablets and capsules), and General Oral Solid Block (general tablets and hard gelatin capsules). The facility spans 81,000 sq.m in Puducherry, India, operational since 2010, with manufacturing equipment from leading global suppliers including Steril Line Italy, Tofflon, ROTA Germany, Truking, Cadmach, ACG, and others.

Differentiator

Problem solved

Functional benefit

Products and services

• Contract Development & Manufacturing (CDMO) End-to-end CDMO services for pharmaceutical companies covering new formulation development in a dedicated R&D facility staffed by 15 formulation scientists and 30 analytical scientists (many with Ph.D.s), technology transfer to GMP, scale-up, process optimization, exhibit batches, and stability studies. Intended for global pharmaceutical firms wanting a single partner from formulation through commercial manufacturing.
• Contract Manufacturing (CMO) Pure contract manufacturing services for pharmaceutical products already developed, including dossier compilation, regulatory submission support, and commercial manufacturing. Includes in-licensing capabilities that allow customers to out-license products with Steril-Gene-prepared dossiers for registration in chosen markets. Designed for pharmaceutical firms needing scalable cGMP-compliant manufacturing capacity.
• Technology Transfer Services Technology transfer services with a dedicated team of 15 scientists and 8 project managers to transfer products from external organizations into the Steril-Gene facility, including feasibility trials, GMP transfer, scale-up, process optimization, exhibit batches, and stability studies. Used by pharmaceutical clients that need a new manufacturing partner for established products or processes.
• Site Transfer Services Site transfer services that add Steril-Gene as a secondary manufacturing site for existing approved products, including transferring existing market authorizations and a dedicated documentation team for regulatory submissions. Designed for pharmaceutical companies that need manufacturing redundancy or secondary supplier qualification.
• Regulatory Services Regulatory services delivered by a dedicated 20+ member regulatory team that prepares dossiers in CTD, ECTD, and ACTD formats for product registrations across various countries. Targeted at pharmaceutical clients needing global regulatory filing support alongside manufacturing or as a standalone service.
• Ampoules (1ml to 10ml) Sterile small-volume parenteral liquid injectables in ampoules ranging from 1ml to 10ml, manufactured in a Class A sterile environment using ROTA Germany ampoule line. Manufactured for pharmaceutical clients that need sterile liquid injectable presentations in ampoule form.
• Vials (1ml to 100ml, including lyophilized vials) Sterile liquid injectables in vials ranging from 1ml to 100ml, including lyophilized vials for highly sensitive molecules, with three Steril Line Italy vial lines and two lyophilizers. Delivered for clients needing liquid vial or freeze-dried injectable presentations.
• Pre-filled Syringes Sterile pre-filled syringes manufactured using Truking equipment line for injectable drug delivery in a Class A environment. Produced for pharmaceutical clients wanting ready-to-inject PFS formats.
• Ophthalmic Vials Sterile ophthalmic vials for eye drop formulations, manufactured using Truking ophthalmic vial line in Class A environment. Made for pharmaceutical clients requiring sterile ophthalmic presentations.
• Hormonal Tablets Hormonal category tablets manufactured in the dedicated Hormone Block with isolator for hormonal API dispensing, 45-station tableting line, and high-speed serialization capabilities. Used for oral contraceptive and hormone replacement therapy presentations requiring segregated facilities.
• Hormonal Softgel Capsules Hormonal category soft gelatin capsules manufactured using a high-speed precise soft gelatin encapsulation line with gel preparation machine, tumble dryers, and alu-alu blister packing. Produced for clients needing hormonal softgel presentations with full containment.
• Potent Tablets Potent category tablets manufactured with isolator for potent API dispensing, Cadmach compression machine, high-speed Rapid pack Alu Alu blister packing with camera sorter, and end-to-end bottle packing line from Parle. Built for clients requiring dedicated containment for highly potent molecules.
• Potent Hard Gelatin Capsules Potent category hard gelatin capsules manufactured using ACG capsule filling machine with check weigher, bag in/bag out AHU system, and high personal safety standards. Suited for clients needing encapsulated potent compounds with dedicated containment.
• General Tablets General category tablets manufactured using Cadmach and HATA compression machines with Rapid pack blister and BQS Alu-Alu packing, and Jekson serialization, in a Class D manufacturing area. Produced for clients needing high-volume standard oral solid dose manufacturing.
• Hard Gelatin Capsules (General) Hard gelatin capsules manufactured using Sejong capsule filling machine with bottle packing line from Parle and Jekson serialization, in a Class D manufacturing area. Made for clients needing standard encapsulated oral solid dose products.
• Pregabalin (in-licensable ready-to-file product) Generic pharmaceutical product (Pregabalin) listed in Steril-Gene's readily available products portfolio, available for customer in-licensing into chosen markets along with dossier documents. Target customers are pharmaceutical firms seeking ready-to-file generic products for distribution in selected geographies.
• Levetiracetam (in-licensable ready-to-file product) Generic pharmaceutical product (Levetiracetam) listed in Steril-Gene's readily available products portfolio, available for customer in-licensing into chosen markets along with dossier documents. Target customers are pharmaceutical firms seeking ready-to-file generic products for distribution in selected geographies.

Quantifiable outcome

• Shorter order conversion time compared to industry standards
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Madras Pharmaceuticals (India)coreStrategic or Co-development PartnerJoint venture partner with over 40 years of pharmaceutical experience in India. Contributes Indian market expertise, formulation development capabilities, and regulatory knowledge for Indian market registrations.
• Lloyd Laboratories (Philippines)coreStrategic or Co-development PartnerJoint venture partner with over 40 years of pharmaceutical experience in the Philippines. Contributes ASEAN region market expertise and manufacturing capabilities, enabling broader regional market access.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Piramal Pharma Solutions: Indian-headquartered CDMO offering sterile injectable fill-finish, oral solid dose, and integrated development services across global pharma clients. Directly comparable to Steril-Gene on multi-dosage-form CDMO with regulated-market approvals.
• Jubilant Pharmova: Indian pharmaceutical company with CDMO services including sterile injectables, APIs, and radiopharma. Comparable as a domestic peer offering contract manufacturing and sterile injectable capabilities.
• Syngene International: India's largest publicly listed CDMO offering drug substance, drug product development, and manufacturing for global pharma and biotech. Comparable as a full-service Indian CDMO with similar target customer base, though Syngene is larger and more biologics-weighted.
• Aurigene Pharmaceutical Services: Indian CDMO offering formulation development, manufacturing, and analytical services across small molecules and biologics. Comparable Indian CDMO serving global pharma with similar B2B services model.
• Sai Life Sciences: Indian CDMO providing drug substance and drug product development & manufacturing services, including sterile injectables, to global pharma. Direct peer in capabilities and customer profile, though with greater biologics focus.

Broad incumbents

• Recipharm: European-headquartered CDMO offering sterile fill-finish, biologics, and oral solid dose across multiple sites globally. Comparable as a broader established CDMO incumbent with overlapping sterile injectable capability, though at much larger scale.
• Thermo Fisher Scientific (Patheon): Global CDMO (Patheon) serving pharma and biotech with sterile manufacturing, oral solids, and integrated development. Comparable as broad incumbent with overlapping services and significantly larger scale and biologics exposure.
• WuXi AppTec / WuXi STA: Global CDMO with extensive sterile injectable, API, and biologics manufacturing capabilities. Comparable broad incumbent serving global pharma with similar services; significantly larger and geographically diversified.
• Catalent (Novo Holdings): Global CDMO leader with deep capabilities in sterile injectables, softgel, and oral dose technology. Comparable broad incumbent with overlapping dosage-form portfolio; significantly larger and more diversified than Steril-Gene.

Emerging players

• Aurobindo Pharma: India-headquartered global generics manufacturer with growing injectable and contract manufacturing operations (Aurobindo Pharma USA / Eugia). Comparable as an Indian injectable-focused manufacturer with emerging CDMO arm and overlapping target markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/steril-gene-life-sciences-private-limited

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

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 Steril-Gene