Omprakash Koshti

Senior General Manager Quality

Role: Senior General Manager at Rubicon Research Limited
Location: Indore, MP, IN
LinkedIn followers: 500 followers

OperationsView LinkedIn profile

Experience

Senior General Manager
Rubicon Research Limited
Oct 2024 — Present

Education

Devi Ahilya Vishwavidyalaya
B. Pharma, Pharmaceuticals
1995 — 1999
Annamalai University
Master of Business Administration - MBA, Self management and Crisis Management

Skills

Good Laboratory Practice (Glp)
Quality System
V&V
Formulation
Gxp
Pharmaceutical Industry
Sop
Fda
Corrective and Preventive Action (Capa)
Change Control
Technology Transfer
Regulatory Requirements
Abbreviated New Drug Application (Anda)
Quality Assurance
Quality Control
Gmp
Standard Operating Procedure (Sop)
Glp
21 Cfr Part 11
Validation
Anda
Verification and Validation (V&V)
Regulatory Affairs
Cleaning Validation
Gamp
Hplc
Capa

Contact information

Verified work emails, personal emails, and direct dials — unlocked in one click.

Work email
•••••@rubicon.co.in
Personal email
•••••@•••••.com
Direct dial
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Current company

Rubicon Research Limited

Pharmaceutical Manufacturing · 1.2K employees · Founded 1999 · Thane, Maharashtra, India

Rubicon Research Limited is an IP-led, pharmaceutical company focused on developing value added products for the pharmaceutical industry as well as developing a portfolio of generic prescription and OTC products across a range of therapeutic categories. We leverage our proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges. Our portfolio spans multiple dosage forms, including oral solids, oral liquids, ophthalmic, nasal, injectable, topical, drug device combinations and fixed-dose combinations. We have 50+ patents in drug delivery technologies, with over 28 approved products in the US. We also have 70+ products in development and 10+ products under review with the US FDA. Our state-of-the-art R&D center in Thane, Maharashtra, is built to GMP standards and equips us to carry out complete: • Oral solid dosage form development from pre-formulation studies up to pilot scale in a single facility • Oral liquid dosage form development suite up to pilot scale • Topical dosage form development suite up to pilot scale • Sterile dosage form development including injectable and ophthalmic dosages • Dedicated containment suite for development of highly potent products including hormonal products and oncology products In 2019, we acquired Impopharma Canada Ltd, establishing Rubicon Research Canada Ltd. This facility supports the development of pulmonary and nasal drug delivery systems and ophthalmic, otic, and dermal products. In 2020, we launched Rubicon Consumer Healthcare, a subsidiary that develops healthcare and personal wellness solutions for the Indian market. In 2020 we also launched Rubicon Academy, a learning platform for pharmaceutical professionals and students. Rubicon Research operates out of 4 locations—the corporate HQ and R&D center in Thane, India, the R&D center in Concord, Canada, the manufacturing site in Ambernath, India, and business development and regulatory office in Plainsboro, US.

rubicon.co.in

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Experience

Senior General Manager

Education

Devi Ahilya Vishwavidyalaya

Annamalai University

Skills

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