Dinesh Chakole

Pharma R&D Leader | Head – Formulation Development -Regulatory Market at Ajanta Pharma Ltd | 26 Years Experience | Generics, NDDS, CGTE, Complex Products | US/EU/Canada Regulatory Expertise

Role: Head Formulation Development- Regulatory Market at Ajanta Pharma Ltd
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

Research & DevelopmentView LinkedIn profile

About Dinesh Chakole

With about 26 years of proven experience in Pharmaceutical Product Development, I…

Experience

Head Formulation Development- Regulatory Market
Ajanta Pharma Ltd
Mar 2021 — Present · Mumbai, IN

Education

Nagpur University
M. Pharm
1997 — 1999
Pacific University
Ph.D. in Pharmaceutic Sciences

Skills

Pharmaceutical Industry
Sop
Abbreviated New Drug Application (Anda)
Dissolution
Product Development
Technology Transfer
V&V
Regulatory Requirements
Gmp
Regulatory Submissions
Pharmacokinetics
Quality by Design
Drug Delivery
Project Management
Research and Development (R&D)
Anda
Cross-Functional Team Leadership
Pharmaceutical Research
Validation
Glp
Good Laboratory Practice (Glp)
R&D
Drug Development
Formulation
Peptides
Pharmaceutics
Regulatory Affairs
Generic Programming

Contact information

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Work email
•••••@ajantapharma.com
Personal email
•••••@•••••.com
Direct dial
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Current company

Ajanta Pharma Ltd

Pharmaceutical Manufacturing · 10K employees · Founded 1973 · Ajanta Tower, 54-A, M Vasanji Road, Chakala, Andheri (E), IN

Ajanta Pharma Limited is a pharmaceutical company headquartered in Mumbai, India. It has strong presence in Branded Generic business in India & Emerging markets; and Generic business in USA. In India, company operates in selected therapeutic areas of Cardiology, Dermatology, Ophthalmology, and Pain management. Recently Ajanta also got into two new promising therapies of Nephrology and Gynaecology. Its brands hold leadership positions in sub-therapeutic areas they are present in. In Emerging Markets, company has presence in Africa, South East Asia, West Asia, and CIS on broader therapeutic segments such as antimalarial, gastro, antibiotics, cardiology, dermatology, pain management, etc. As on 30th Mar 2026, Ajanta has 49 ANDA approvals, out of which 49 are commercialised. It is awaiting US FDA approval for 19 ANDAs. Company plans to file 8-12 ANDAs every year. Company has state-of-the-art research facilities for formulation and API development located at Mumbai, India. R&D capabilities are evident from number of 1st to market products launched by the company providing patients most needed compliance and convenience. A dedicated and focused team of over 850 scientists work for R&D, which is growing continuously. Ajanta has 6 formulations manufacturing facilities located in India. Besides that, it also has an API manufacturing facility located at Waluj, India. Ajanta’s flagship formulation facilities at Paithan (Maharashtra, India) and Dahej (Gujarat, India) have been approved by US FDA. Ajanta continuously invests in enhancing the existing manufacturing facilities to meet current cGMP requirements and also construct new facilities to meet company’s growth requirements. Please visit https://ajantapharma.com/ for more information.

ajantapharma.com

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About Dinesh Chakole

Experience

Head Formulation Development- Regulatory Market

Education

Nagpur University

Pacific University

Skills

Find verified contacts for anyone on LinkedIn