Ajay Khedkar

Regulatory Affairs Manager at Umedica Laboratories Private Limited

Ajay Khedkar is a Regulatory Affairs Manager with experience in leading regulatory activities for various pharmaceutical companies such as Umedica Laboratories, Amipharma Laboratories Ltd., and Amneal Pharmaceuticals India Pvt. Ltd. Ajay holds a Master's degree in Pharmacy and has a strong background in preparing and reviewing regulatory submissions, dossier preparation, deficiency response, and ensuring compliance with regulatory guidelines.

Location

Pune, India

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Umedica Laboratories Private Limited

UMEDICA is a part of the Amoli Group of Companies, manufacturing and exporting a wide range of formulations viz; Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA offers a diverse product portfolio with a patient-centric approach comprising of antibiotics, anti-diabetics, anti-hyperlipidemic, anti-hypertensives, non-steroidal anti-inflammatory (NSAIDs), analgesics, antifungal, anti-malarial, antihistaminics , psychotropic, diuretics ,anti-hypertensives, drugs for sexual dysfunction and multivitamins etc. We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement. UMEDICA's manufacturing facility, located in Vapi, Gujarat is a WHO GMP approved, US FDA, EU, Health Canada, TGA & UAE MoH approved facility. The facility has also been audited and approved by Regulatory authorities of various countries viz. USA, EU, Australia, Canada, UAE, Zimbabwe, Ethiopia, Tanzania, Nigeria, Uganda, Kenya, Ghana, Ivory Coast, Malawi etc. Umedica is equipped with an RnD Centre which is staffed by well qualified and experienced team of scientists to develop new formulations. Umedica has 11 approved ANDAs and 10 different products approved in EU & UK. Umedica is well versed with Regulatory Affairs essential for Registrations and Regulatory Compliance in various countries all over the globe. UMEDICA has business operations in more than 85 countries covering US, EU, Canada, Australia, Middle East, Central & South American countries, Africa, Asian & CIS countries. UMEDICA is a Government recognized Export House that has been awarded ‘Chemexcil’ Top Export Award for performance in exports.


Headquarters

Mumbai , India

Employees

1,001-5,000

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