Aniket Dighe

Regulatory Affairs Executive at Ajanta Pharma | Biopharmaceutics, Formulation Development, and Regulatory Strategies | Ex-BBRC (Bristol Myers Squibb), Ex-Lupin & Ex-Zydus

Role: Executive at Ajanta Pharma Ltd
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

Experience

Executive
Ajanta Pharma Ltd
May 2024 — Present · Mumbai, IN
Regulatory Affairs professional with hands-on experience in ANDA filing for the US market, CMC documentation, FDA query responses, variation submissions, and post-approval changes. Skilled in managing change control activities, maintaining Quality Management Systems (QMS), and ensuring regulatory compliance across product lifecycles. Proven ability to coordinate with cross-functional teams to drive timely and successful regulatory submissions.

Education

Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm
2012 — 2016
Savitribai Phule Pune University
Master's degree
2016 — 2018

Contact information

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Work email
•••••@ajantapharma.com
Personal email
•••••@•••••.com
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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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Experience

Executive

Education

Savitribai Phule Pune University

Savitribai Phule Pune University

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