Flow Reactor - Hero Section

PRODUCT REGISTRATION

Advanced Bioreactors for Intelligent Bioprocessing

Fit-for-purpose design. AI-enabled control. Seamless scale-up.

Under the Drugs and Cosmetics Act 1940 and Rules 1945 the Ministry of health and Family Welfare passed a set of laws giving authority to the Drugs Controller General of India (DCGI) to regulate the quality of drug product and drug substance imported into India or manufactured in India . The DCGI is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licenses of specified categories of drugs.

The DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India. For Overseas manufacturers the DCGI requires the Drug and Medical Device manufacturers to register their products in India through an agent who must be a holder of a valid FDA license.

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Our Flagship Projects

Rifa Pharma supports its suppliers during the process of submitting applications for API’s , Finished Products and medical devices as per the client requirement. Our team of qualified experts will successfully review , compile and submit the regulatory documents for the international clients as per DCGI requirements . These applications include:

→API Registration

→ Drug Product Registration

→Test License

→Medical Devices Registration

→Import License

API REGISTRATION

Requirement :

Dossier as per DCGI Guidelines.

Time Taken : 8 to 12 months

Factory Registration

(if demanded by DCGI)

$10000

Product Registration

(if demanded by DCGI)

$5000

Factory Inspection

(if demanded by DCGI)

$25000

New Drug Application

(if demanded by DCGI)

$35000

Contact Table
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Name

phoneicon

Contact Number

emailicon

Email

Dr Sanjay Loomba +91 8121007791 sanjay@rifapharma.com

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Medical Devices Expert

Connect with our Medical Devices Specialist for product guidance, technical support, and partnership inquiries.

Name

Contact Number

Email

Disha Desai +91 96194 94942 disha.desai@rifapharma.com


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      Disha Desai

      Medical Devices and
Packaging Solutions

      Ms. Desai has masterfully elevated the valuation of the Packaging and Medical Devices division, breaking barriers and unlocking new opportunities. She is an invaluable force with over 10+ years of expertise and a portfolio of 30+ customer companies. Her relentless hustle, strategic vision, and unwavering determination not only seize opportunities but create them, driving unprecedented growth and success.

      Ms Ujwala Parkhe

      Veterinary APIs & Premixes, Nutraceutical APIs

      Ms. Ujwala is a razor-sharp professional with an unwavering focus on delivering results. With deep expertise in the veterinary premix market, she ensures every promise and goal is achieved. Her tenacity, proficiency with active ingredients, and strategic foresight set her apart. Leading sales and new developments at Rifa Pharma, she drives innovation, sustainability, and impactful growth, making her a trusted advisor and partner in success.

      Dr Sanjay Loomba

      CEO at Rifa Pharma

      Our CEO and partner - Dr. Sanjay Loomba, a trauma surgeon and visionary leader, brings over 18 years of expertise in healthcare and the pharmaceutical industry. He has been instrumental in establishing advanced manufacturing facilities and optimising procurement for global markets. Currently, at Rifa Pharma, he focuses on driving innovation, enhancing operational excellence, promoting sustainability, and delivering patient-centric solutions that address the evolving needs of the healthcare sector.

      Neha Thakore

      Managing Partner at Rifa Pharma

      Neha is a dynamic and accomplished leader at Rifa Pharma, bringing over 25 years of expertise in the pharmaceutical industry, with a strong focus on operations. She is highly proficient in business development and regulatory affairs, successfully securing global approvals and driving impactful market expansion. As the Vice Chairperson of the IDMA Bulk Drug Committee, she plays a pivotal role in enhancing industry influence. Her comprehensive expertise extends across corporate governance, ESG strategy, and stakeholder engagement, ensuring sustainable growth and unwavering compliance excellence..

      Anant Thakore

      Founder

      Anant Thakore embodies resilience, vision, and leadership.Stepping in during a critical phase, he revolutionized the company,driving it to a remarkable $60 million indenting enterprise.A true pioneer in India’s pharmaceutical landscape,he played a crucial role in advancing anti-tuberculosis and antibiotic manufacturing. His groundbreaking achievements include becoming the first indigenous manufacturer of corticosteroids,solidifying his legacy as a transformative force in the industry.