Wide gamut services across the development chain:

Chemistry

  • Hit to Lead
  • Lead Optimisation

Pre-clinical

  • Synthesis and Purification
  • Ref. Standard and Impurities

Phase 1- Phase 3

  • Process Optimisation through Process Understanding
  • cGMP Production

Commercial

  • Process Validation
  • Manufacturing
  • Life-Cycle Management

Chemical Process Design, Development and Optimisation:

  • Route Scouting
  • Tech Transfer Services
  • Chemical Process Engineering
  • Salt and Polymorph Screening
  • Process Development and Optimisation through process understanding
  • Identification and Characterisation of Impurities
  • Chemical Process Safety
  • Kilo Lab Manufacturing and Scaleup

Process Analytical Research and Development:

We have US-FDA audited and approved analytical laboratory facility with 21CFR Part 11 compliance systems.

  • Method development
  • Method validation and transfer
  • Polymorph screening
  • Forced degradation studies
  • Impurity isolation and characterisation
  • Stability studies
  • Elemental impurities profiling
  • Genotoxic assessment

Robust framework for IP protection:

We have US-FDA audited and approved analytical laboratory facility with 21CFR Part 11 compliance systems.

  • Mandatory CDA for all employees to ensure confidentiality
  • Well established data systems for protection of information at all levels
  • All programs driven by customer need with no internal programs
  • IP assigned to clients at the beginning of relationships

As one of the leading providers of specialised API services, Solara Active Pharma Sciences offer a full spectrum of contract development and manufacturing solutions to clients worldwide powered by its Research & Development (R&D) Centre.

Our capabilities span the entire value chain of a novel chemical entity—from early discovery to late-stage commercialisation—and include analytical services, impurity synthesis, and regulatory support. With a relentless focus on client satisfaction and retention, we manufacture at scale and offer unparalleled expertise in process development for early-phase drug-development compounds.

Our world-class quality standards and global accreditations for GMP manufacturing have earned us the trust of pharmaceutical companies across North America, Europe, and Japan. As we continue to expand our footprint, we are exploring niche technologies that will set us apart as the partner of choice for clients seeking innovation and excellence in API services.

Manufacturing Locations

Ambernath, Maharashtra

  • Reactor Details: 250L - 8000L
  • Temperature: -20 °C to + 130 °C
  • Material of Construction: SS, GL, SS-GL, MS-GL
  • Packaging Control: Meet requirements of ISO Class - 8
  • Compliances: USFDA, EDQM

Cuddalore, Tamilnadu

  • Reactor Details: Size ranges from 250L to 12500L
  • Temperature: -90 °C to + 200 °C
  • Material of Construction: SS, GL, MSGL, Hastelloy
  • Packing Control: Meet requirements of ISO Class – 8
  • Compliances: USFDA, EDQM, KFDA (Korea), EU-GMP (Danish), WHO (Geneva), MHRA, Cofepris (Mexico), TGA (Australia), PMDA (Japan)

Mangaluru, Karnataka

  • Reactor Details: Size ranges from 250L to 6300L; Glass reactors of 20L – 250L
  • Temperature: -20 °C to + 130 °C
  • Material of Construction: SS, GL,
  • Packaging Control: Meet requirements of ISO Class - 8
  • Compliances: USFDA, EDQM, KDFA (Korea), WHO (Geneva), TGA (Australia)

Pondicherry

  • Reactor Details: Range between 1200 L to 12,500 L
  • Material of Construction: SS, MSGL, GL
  • Packing Control: Meet requirements of ISO Class – 8
  • Compliances: USFDA, EDQM, AGES (Austria), KFDA (Korea), EU-GMP (Danish), MHRA, Cofepris (Mexico), PMDA (Japan)

Mysore

  • Reactor Details: Range between 1200 LTR to 5000 LTR
  • Hydrogenator Capacity 50 LTR to 4000 LTR with 15Kg pressure
  • Temperature 20 to 130 degree Celsius
  • Compliances - No Regulatory Compliance

Vizag

  • 1st Phase in 17 Acers. Total 4 Blocks with multi purpose products, 3 Blocs are fully operative
  • 2nd Phase in 23 Acers
  • Reactor Details: 100 L to 25000 L
  • Temperature: -40 C to +250 C
  • Material of Construction: SS, GL, SS-GL, MS-GL, Hastelloy
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