
Optimus Drugs Private Limited
End-to-end CDMO solutions for small molecule drug substances and drug products, from clinical development to commercial manufacturing.
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.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Manufacturing (M)
Fill-finish formats
Regulatory clearances
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
Indications
About this organization
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.
Certifications
Locations
Headquarters
India
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