---
name: Optimus Drugs Private Limited
slug: optimuspharma
site: cdmo
website_domain: optimuspharma.com
summary: Leading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities. Headquartered in India.
tagline: End-to-end CDMO solutions for small molecule drug substances and drug products, from clinical development to commercial manufacturing.
founded_year: 2004
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: IN
tier2_domain_verified: false
updated_at: 2026-09-19T07:01:33.563Z
services_count: 11
modalities_count: 1
indications_count: 4
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Optimus Drugs Private Limited

End-to-end CDMO solutions for small molecule drug substances and drug products, from clinical development to commercial manufacturing.

Listed on cdmo.directory.

## Summary

Leading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities. Headquartered in India.

## At a glance

- Founded: 2004
- HQ country: IN

## Services

- CMC Analytical Development
- Topical & Semi-Solid Manufacturing
- Quality Control Testing
- Stability Testing & Storage
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Process Development
- Formulation Development
- Oral Solid Dosage Manufacturing
- Technology Transfer
- CMC Regulatory Submission Support

## Modalities

- Small Molecule

## Indications

- Metabolic
- Cardiovascular
- Neurology
- Infectious Disease

## Locations

- Headquarters, India

## Certifications

- US FDA; Identifier: FDA approval (FDF facility); Source: https://optimuspharma.com/about
- EMA; Identifier: EU GMP approval; Source: https://optimuspharma.com/about
- ANVISA; Identifier: ANVISA audit clearance (Unit 1); Source: https://optimuspharma.com/about
- WHO; Identifier: WHO GMP audit clearance; Source: https://optimuspharma.com/about

## Long description

Optimus Drugs is a Contract Development and Manufacturing Organization (CDMO) specializing in small molecule pharmaceuticals. The company offers integrated, end-to-end solutions spanning drug substance intermediates, drug substance (APIs), drug product intermediates, and finished drug products including oral solids, semi-solids, and controlled-release formulations.

**Service Portfolio:**
- Drug Substance Intermediates: custom synthesis, scale-up, cGMP/non-GMP manufacturing from clinical to commercial scale
- Drug Substance: small molecule API development and manufacturing across NCE/NDA, custom APIs, and generic APIs
- Drug Product Intermediates: pellets, micronized APIs, spray-dried materials
- Drug Product: oral solids, semi-solids, immediate and controlled-release formulations with seamless tech transfer support

**Regulatory & Quality:**
The company maintains GMP-certified manufacturing with successful audits by USFDA, EU GMP, ANVISA, WHO, TGA, and EDQM. Founded in 2004 as a custom synthesis laboratory, Optimus has grown into a globally recognized pharmaceutical manufacturer with a strong presence across the small molecule value chain.

**Therapeutic Focus:**
Manufactures products across Diabetes, Cardiac, Neurology, Anti-bacterial, and Anti-fungal therapies. The company is majority-owned by Sekhmet Pharmaventures (acquired May 2022), part of the Gamot API platform based in Singapore.

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_Profile last updated: 2026-09-19T07:01:33.563Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.