API
Breaking through limits
Expanding our API business globally through product diversification and strategic launches.
Active Pharmaceutical Ingredients
At Solara Active Pharma Sciences, we pride ourselves on our ability to design and manufacture top-quality commercial APIs across a wide range of therapeutic categories. With a distinguished history spanning over three decades, we have developed an impressive track record of success in bringing to market complex products, including cutting-edge polymer-based APIs and injectables. Our wealth of experience and expertise in the API industry enables us to offer our valued clients exceptional service, with a focus on delivering high-value products. As of today, we offer over 60 commercial APIs, with 10 additional APIs currently in the development pipeline. Our commitment to excellence has earned us a loyal following of customers in over 75 countries worldwide.
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: PMDA, Geneva, CDSCO,South Korea, USFDA, EDQM
Manufacturing Locations
Ambernath, Maharashtra
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: PMDA, Geneva, CDSCO,South Korea, USFDA, EDQM
Cuddalore, Tamilnadu
Cuddalore, Tamilnadu
- Reactor Capacity- 25 KL capacity
- Spray Drying and Hydrogenation Commercial
- Temperature: -90 °C to + 200 °C
- Material of Construction: SS, GL, MSGL, Hastelloy
- Packing Control: Meet requirements of ISO Class – 8
- Compliances: SUKL Czech Republic, USFDA, EDQM, KFDA (Korea), EU-GMP (Danish), WHO (Geneva), MHRA, Cofepris (Mexico), TGA (Australia), PMDA (Japan)
Mangaluru, Karnataka
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: Spain, CDSCO, USFDA, EDQM, KDFA (Korea), WHO (Geneva), TGA (Australia)
Pondicherry
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: Ireland, USFDA, EDQM, AGES (Austria), KFDA (Korea), EU-GMP (Danish), MHRA, Cofepris (Mexico), PMDA (Japan)
Mysore
Mysore
- Reactor Capacity- 5KL
- Hydrogenation Commercial Scale.
- Material of Construction: SS, MSGL, GL
- Packing Control: Meet requirements of ISO Class – 8
- Compliances: Only Valid Local GMP Certificate
Vizag
Vizag
- Reactor capacity must be 25KL
- Lyophilization: commercial scale
- Material of Construction: SS, MSGL, GL
- Packing Control: Meet requirements of ISO Class – 8
- Compliances: USFDA, EDQM, CDSCO
Manufacturing Capabilities
- Mirrored facilities for developing productsthrough highly automated and stringent qualitysystems
- Focus on technology and production processesthat represent a clear advantage
- Capabilities in high vacuum distillation, hydrogenation, halogenation, grignard reaction,and polymer chemistry, lyophilisation amongothers
- Globally compliant API facilities with necessaryregulatory approvals and adherence to highestquality standards
- Capacity created to ensure minimised concentration risk
- Flexible manufacturing can cater to both largevolume APIs as well as small volume APIs
- Industry-leading talent pool capable of handlinga broad array of manufacturing requirements
