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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.

Services

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

AuthorityIdentifierSource
US FDAFDA approval (FDF facility)View
EMAEU GMP approvalView
ANVISAANVISA audit clearance (Unit 1)View
WHOWHO GMP audit clearanceView

Locations

  • Headquarters

    India

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