Laurus Labs

Laurus Generics FDF

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.

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 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 has a commercial capacity of 5 billion units per year.

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.

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/Profile 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

Nine ANDAs, one NDA with USFDA, one dossier in Canada, four dossiers in Europe, five dossier with WHO, two dossier in South Africa & 22 in ROW.

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