About Us

Laurus Synthesis is a leading Contract Development & Manufacturing Organization (CDMO) with a solid track record in supporting drug development and manufacturing programs of global pharmaceutical and biotech companies. Our state of the art facilities in the US (Woburn, MA) and India (Hyderabad and Visakapatnam) and experienced scientific teams have been supporting our customers for over 10 years in meeting the challenges in drug development programs from early phase development to commercial manufacturing. We are part of Laurus Labs, a fortune 500 company, one of India’s large pharmaceutical companies.

Laurus Synthesis is a leading Contract Development & Manufacturing Organization (CDMO) with a solid track record in supporting drug development and manufacturing programs of global pharmaceutical and biotech companies. Our state of the art facilities in the US (Woburn, MA) and India (Hyderabad and Visakapatnam) and experienced scientific teams have been supporting our customers for over 10 years in meeting the challenges in drug development programs from early phase development to commercial manufacturing. We are part of Laurus Labs, a fortune 500 company, one of India’s large pharmaceutical companies.

Services

1. Contract Development and
Manufacturing Services

Pre-Clinical
Phase I
Phase II
Phase III
Commercial

Non - GMP
&
GMP Synthesis

Pre-Clinical | Phase-I | Phase-II | Phase-III | Commercial

All

Quick process development for med chem synthetic route & non-GMP/GMP scale up to few kg; Analytical data support as needed at early clinical phase.

Pre-Clinical | Phase-I

Pre-Clinical | Phase-I

Route Finalization, full process optimization using QBD approach; GTI evaluation; Analytical method development & validation; Process Validation & Support NDA filling clinical supplies; Commerical manufacturing

Phase-II | Phase-III | Commercial

Phase-II | Phase-III | Commercial

Tech- Transfer of API/ Regulatory Intermediates/ key starting materials

Phase-II | Phase-III | Commercial

Commercial


2. Niche Solutions

HP API
  • Extensive experience in handling manufacture of Highly-Potent (Cytotoxic and Steroidal Hormones) APIs & Intermediates both at pilot scale & commercial scale.
  • Dedicated cGMP Containment manufacture capability at all scales. 3-5kg batch size at Hyderabad and up to 50kg batch size at Vizag facility.
  • Facilities designed for enabling operational containment levels of Occupational Exposure Limit (OEL) < 1μg/m3
Chiral Separations
  • Conventional column chromatography capability laboratory, pilot and commercial scale.
  • Adequate preparatory HPLC expertise & capacities: Lab scale (100ml/min) to pilot scale (1000ml/min) (Agilent & Knauer) & Column packers (Novasep & Asahi Kasei)
  • Pilot scale to commercial scale SMB installations - Novasep varicol 6X50mm at pilot-scale & 5X300mm at commercial scale
Integrated Drug Development Services
  • Laurus offers integrated drug substance and drug product solutions, from early clinical Phase I to commercial scale production, supported by collaborative teams throughout the program with industry-leading expertize. Our development and manufacturing sites work in sync to offer highly integrated operations to mitigate your supply chain risks. Our drug substance and drug product manufacturing sites have been audited by global regulatory agencies including USFDA.

QUALITY CULTURE

Complex Chemistry

Technical, Handling & sourcing

Manufacturing capacities of >4000 KL

To support supplies for early clinical phase to commercial

Experience in Regulatory submission

To support IND, NDA & DMF filings

High potency API/intermediate Synthesis

Cytotoxic & Hormonal; category III & IV

Emphasis on process safety

Dedicated lab & team for hazard evaluation

Backward intregation of key Starting Material

Reduce uncertanity in supply chain & overall cost of goods

What sets us apart?

We have vast experience in handling development candidates for clients at all stages of the drug lifecycle from route identification to custom synthesis and early clinical to commercialization. Our development and manufacturing teams maintain a tight focus on performance at scale, continuous process improvement, securing and de-risking supply chains to provide an efficient, compliant, cost-effective and long-term commercial drug substance solution.

How we helped our partners

Supply of Key Starting Material and Regulatory Intermediate for a North American Biotech


Scaling up complex synthesis to support a Biotech’s drug development program


Journey of a clinical candidate from Pre-clinical to Phase III at Laurus



Our Customers

Our diverse customer base ranges from small to mid-sized biotech companies, speciality pharma, as well as some of the world’s largest pharmaceutical firms. Many of these companies arrived at our door due to our performance, dependability and unrivalled quality compliance culture, we journeyed with them from late preclinical, through to regulatory submissions of their NCEs all the way to commercialization.

Our Facilities