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Laurus offers its globally compliant cGMP facilities, along with its chemistry expertise and experience, to its customers for contract development and manufacturing of APIs and intermediates.

With proven capabilities to meet and exceed the clients’ requirements in terms of quality, regulatory and IP needs as well as cost targets, Laurus Labs aims to provide a total API solution to the global market.

Laurus is continuously extending its portfolio to include focus on molecules in other therapy areas where it feels it can establish a leading position.

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Building on our strong capabilities in chemical development and manufacturing, Laurus Labs has developed an in-house range of APIs and related intermediates. Focusing on chemistries where we can make a difference, Laurus combined innovation with efficiency by developing cost effective processes while simultaneously investing in suitable capacities to ensure reliability of supply.

Laurus is one of the world’s leading suppliers of anti-retroviral APIs & intermediates and we believe our low cost technologies in this critical segment will help increase access to medicine for those in need throughout the world. Laurus works closely with leading innovators, global health organizations and providers to ensure cost reduction targets are met without compromising quality standards.

With state-of-the-art facilities to handle highly potent materials at both developmental and commercial scale, Laurus considers Oncology one of its core competencies and offers a comprehensive range of APIs in this segment.

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We are building on Laurus R&D’s strengths in chemistry research, process chemistry, active pharmaceutical ingredient production and regulatory filings to forward integrate to FDF Business. FDF business is committed to strengthen and further enhance Laurus’ vision of becoming a leading player in offering integrated solutions to global pharmaceutical needs.

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formulation research labs, laboratory scale clinical supply facility & analytical research labs capable of developing different types of dosage form.

As Laurus has established a strong competency in development and manufacture of potent molecules, it is also our intention to establish capability to manufacture potent oral products.

In parallel, Laurus is establishing state of art oral finished dosage facilities conforming to international regulatory standards. The facility will have a pilot plant and initial commercial capacity of 1 billion units, expanding to 5 billion units over time, with investment of US$50million.

The Finished Dosage Form Development center is an integral part of Laurus R&D, comprising of Formulation and Analytical Research, Clinical Pharmacodynamics and Pharmacokinetics, Regulatory Affairs, Packaging Development, Intellectual Property Management and Developmental QA departments. Laurus has dedicated

We Solicit Partnerships / Alliances with potential business partners for :

Out-licensing of projects from our development pipeline

Joint Product Development with manufacture and supply of Finished Dosage Forms

Work with partner jointly on early launch opportunities - advantages of API or FDF innovation - Licensing/Royalty/Profit Share based business model

Life cycle management utilizing Laurus’ ability to be the “last-man-standing” in key molecules

Site Transfer and Contract manufacture for the Regulated Markets

Two ANDAs and one WHO dossier filed.

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• Integration Benefits• Cost Effective API

Process• Large Capacities• Continuous process

improvements

Market FDF Price

Laurus’ Total Value AddMarket API Price

Laurus’ API Value Add

Laurus APICOGS

LaurusFinishedDosageCOGS

Laurus is forward integrating into finished dosage forms (FDF) to create more value, generated through its cost effective processes and large capacities in the API business, for its customers.

Trusted, recognized and credible

API solution provider

API and Finished dosage solution

providerForwardIntegration

Business Units

The core-strength of Laurus is its innovative, robust & scalable chemistry - making use of which, multiple developmental candidates of client organizations have been handled at all stages of drug lifecycle right from route identification through to custom synthesis and from early clinical through to commercialization. Even while handling semi-mature processes of late-phase clinical candidates OR while conducting tech-transfer of mature processes of marketed APIs &/ or KSMs for eventual contract manufacture, our development & manufacturing teams have a tight focus on aspects such as performance at scale, continuous process improvement, securing and de-risking supply chain et al thus providing an efficient, compliant, cost-effective and long-term commercial drug substance solution.

The strong analytical chemistry team at Laurus works closely with the chemical development & tech-transfer teams as the process evolves & provides all necessary and phase-appropriate support to the client organizations involved on their drug substance as well as drug product analytical development needs. The drug product development team at Laurus is fully capable & equipped to develop all type of formulations both for NCEs & Generics and other specialty products. This capability is ably complemented by the comprehensive analytical infrastructure in place.

While the Indian operations service the global clients, taking into cognizance a need for intensive iteration with their CRO partners of a section of drug discovery, pharm-outsourcers in USA, Laurus established a fully owned subsidiary Laurus Synthesis Inc. in the drug-discovery hotbed of Boston, MA. The high caliber team here can support clients on their early to late-stage chemical development needs and work in tandem with the India site for providing a complete scale-up solution to the North American client organizations bringing to them, literally the best of both worlds.

With strengths in flexi-scale drug substance manufacturing & phase appropriate chemical & analytical development capabilities, Laurus labs is well positioned to meet all NCE drug substance needs of the client, preclinical through to commercial manufacture.

Utilizing the core competencies of the specialized work-force and the manufacturing expertise within the larger organization, Laurus synthesis division offers services in two distinct segments of Contract Manufacture & Contract Development.

CONTRACT DEVELOPMENT

Chemical process developmentDrug substance manufacture, including HPAPIs CMC & regulatory support Custom synthesis

Method developmentMethod validationStability studies Impurity identification, characterizationReference standard characterization

Pre-formulation studiesDosage form development for NCEsFormulation development for ANDA submissions

Drug Substance Services••••Analytical Development Services•••••Product Development Services•••

CONTRACT MANUFACTURE

Tech-transfer from client sites aided by effective project management Secure RM supply chain by continuing the existing sources & identifying new cost-effective sources &/or back-integrating the manufacture where possibleCustom build and dedicate equipment trains/ blocks/ manufacturing facilities as required

Large-scale chiral separations utilizing the pilot & commercial-scale SMB capabilitiesCollaborative models including IP-share, revenue-share models of development, facility deployment and manufacture

APIs & Starting Material•

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There is a strong and welcome trend worldwide of consumers adopting a lifestyle of holistic wellness, in which nutritional supplements play an important role. Laurus Labs has been at the forefront of developing innovative and patented technologies and manufacture of highly pure, well characterized specialty ingredients for use in dietary supplements and cosmeceutical products.

Laurus has gained the leadership position in manufacture and supply of nature identical and highly pure polyphenols (Curcumin, Resveratrol, Pterostilbene etc.) and successfully developed technologies for carotenoids (Betacarotene, Astaxanthin), Huperzine A and novel nutraceutical co-crystals of Pterostilbene, Caffeine, Curcumin etc. for their enhanced bio-availability/controlled absorption.

Laurus also manufacture natural ingredients of proven efficacy and safety for weight management, sports nutrition, joint health, metabolic disorders, eye health, skin care and general wellbeing. With manufacturing and quality rigor matching that of the pharmaceutical APIs and international compliances of GMP, Kosher, Halal and HACCP etc., our Ingredients have gained a global reputation for consistent quality and assurance of supply.

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Located in Hyderabad, a key pharmaceutical center of India, Laurus’ State of the art R&D center is the hub of focused scientific activity. The scientific teams here not only develop, optimize scientific & technological solutions but also ensure these innovations are scalable & compatible with the market realities.

10-acre campus at IKP Genome Valley

700+ scientific staff in R&D space with dedicated labs for chemical development, analytical development & formulation development

Pilot plant incl. a fully contained block for “high potent Manufacturing facility”

Small volume GMP manufacture of non-potent & highly-potent APIs

USFDA, TGA, KFDA and PMDA approved

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Facilities

Research & Development Center Hyderabad

Located in Visakhapatnam (Vizag), a coastal city & an emerging pharmaceutical hub, these state-of-the-art facilities have been built to the most demanding global standards. The manufacturing team here works closely with the research & development team at Hyderabad to transfer-in, validate & commercialize the manufacturing processes.

34-acres campus in Jawaharlal Nehru Pharma City

760,000 sft of built-up space with 1,140,000L of installed capacity

Commercial-scale manufacture of non-potent & highly-potent APIs

USFDA, MHRA, TGA, KFDA, WHO-cGMP and PMDA approved

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Drug Substance Manufacturing Facilities Vizag

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Special Capabilities

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45-acres campus in Special Economic Zone (SEZ) at Achutapuram (21km from Unit 1)

Integrated manufacturing site for API and Finished Dosage Forms

USFDA Inspection completed during December 2016

Facilities

Manufacturing Facilities Vizag

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40-acres campus in Jawaharlal Nehru Pharma City, located adjacent to Unit 1 and operating under the same FDA establishment number450,000sft of built-up space with over 650,000 L of installed capacityCommercial-scale manufacture of APIsUSFDA, WHO-cGMP and EU-GMP approved

44-acres campus in Achutapuram (21km from Unit 1) Manufacturing facility focused on backward integration into key starting materials and intermediates in addition to solvent recovery will be operational in 2016

9-Acre site in Special Economic Zone (SEZ) at Jawaharlal Nehru Pharma City dedicated for hormonal APIs is inaugurated and operational

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Digitally controlled normal pressure large scale silica gel chromatography is used to manufacture APIs at the scale of 1ton/month. 6-columns with 670 mm diameter and 6 mts in height are used in coordination with Falling Film Evaporators (FFE) for fraction enrichment.

T h e c o n t i n u o u s s i m u l a t e d m o v i n g b e d chromatographic system is being extensively used to separate the racemic mixture in industrial scale at Laurus. VARICOL form NOVASEP is installed with a capacity to process 15tons/month of racemic mixture.

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SYSTEMS: Quality, Regulatory, EHS and IP

Quality Policy

Regulatory Compliance

Environment, Health & Safety

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Laurus labs is committed to maintain best Quality Standards in Research & Development, Contract Services and Manufacturing of Pharmaceutical products through periodic reviews and continuous improvement of Quality Management System, and strive to enhance customer satisfaction.

Laurus Labs is fully committed to ensure that our manufacturing facilities comply with international regulations for current Good Manufacturing Practice (cGMP); Good Laboratory Practice (GLP) & all locally applicable regulatory requirementsWe have been inspected by most regulatory bodies including USFDA, MHRA, TGA, KFDA, WHO-cGMP and PMDAWe have experience in filing DMF’s in accordance with the requirements of FDA(USDMF), EDQM(CEP), ICH(ASMF in ECTD format), PMDA(J-DMF) & other agencies.We have obtained written confirmation for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC

Laurus is committed to;Mitigate the environmental impact of its activities, products and services

Intellectual Property•

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Committed to respect valid Intellectual Property globally

Laurus Labs have extensive experience in reviewing the patents and understanding the relevance of IP landscape. We also work with customers and third parties to validate the information.

Laurus Labs is well versed with the procedural requirements of filing patents & have filed in various jurisdictions such as US, UK, INDIA & PCT.

Guidelines, SOPs in place for handling of Client IP received & generated in course of delivery

All employees are signatories to non-disclosure agreement on all proprietary information

Any IP generated on projects fully sponsored by the client is owned by the client

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Protect and promote the health and well being of its employeesEquip, establish and operate its facilities to highest safety standards

Manufacturing FacilitiesVizag, Andhra Pradesh

State-of-the-Art R&D Centre Hyderabad, Telangana