Key Milestones
MEDICAMEN Biotech has constantly strived to be on the path of growth on the strength of its brilliant human resource, world class facilities and a global vision of its Management.
From being a purely Formulation manufacturer of general products, the Company has diversified into setting up a state-of-the-art R&D Centre followed by a most modern API manufacturing facility and, lastly, setting up a highly auditable facility for manufacturing Oncology injectables and OSDs which will stand the test of leading global regulatory agencies. Please find below our journey from humble beginnings to being a vertically integrated Group:
Chronology of Events
Medicamen established.
IPO issued – BSE listed.
Operations started - Bhiwadi FDF Plant.
WHO-GMP Received – Bhiwadi FDF Plant.
ISO certification – Bhiwadi FDF Plant.
Global Accreditation: NDA(Uganda), ANVISA(Brazil), FM HACA(Ethiopia) – Bhiwadi FDF Plant.
Operations started – Haridwar Unit-I (FDF).
Shivalik Rasayan Ltd takes controlling stake of Medicamen Biotech Ltd.
New R&D center setup along with Upgradation & Modernization of Bhiwadi FDF Plant.
Global Accreditation: FABD(Philippines), CECMED(Cuba) – Bhiwadi FDF Plant.
Global API Facility started – Dahej API Plant.
Operations started: Haridwar Formulation Unit – II(FDF) (Oncology).
Filing API USDMFs & CEPs.
Launch of Medicamen Lifesciences
Medicamen Lifesciences, a subsidiary of Medicamen Biotech, started operations in 2022. It focuses on manufacturing and marketing pharmaceutical products, particularly Anti-hypertensives, Antidiabetics, and Cardiology.
It operates eight manufacturing facilities meeting WHO, EU-GMP, and USFDA standards, with plans to expand nationwide.
Medicamen Lifesciences, a subsidiary of Medicamen Biotech, started operations in 2022. It focuses on manufacturing and marketing pharmaceutical products, particularly Anti-hypertensives, Antidiabetics, and Cardiology.
It operates eight manufacturing facilities meeting WHO, EU-GMP, and USFDA standards, with plans to expand nationwide.
First ANDA Filing
Medicamen filed its first Abbreviated New Drug Application (ANDA) with the USFDA for Bortezomib injection 3.5 mg, marking a significant milestone in its oncology portfolio.
Medicamen filed its first Abbreviated New Drug Application (ANDA) with the USFDA for Bortezomib injection 3.5 mg, marking a significant milestone in its oncology portfolio.
USFDA Audit
The Oncology Plant in Haridwar underwent a USFDA audit in April 2023, positioning it for potential approvals in regulated markets such as the US and the Middle East.
The Oncology Plant in Haridwar underwent a USFDA audit in April 2023, positioning it for potential approvals in regulated markets such as the US and the Middle East.
USFDA Approval Anticipation
We are optimistic about receiving USFDA approval for our Oncology Plant, which will unlock opportunities in regulated markets, particularly in the US and Middle East.
We are optimistic about receiving USFDA approval for our Oncology Plant, which will unlock opportunities in regulated markets, particularly in the US and Middle East.
EU Approval
Medicamen Biotech’s Bhiwadi Manufacturing Facility achieves European Union GMP Approval from MOH, Greece.
Our state-of-the-art manufacturing facility at Bhiwadi, Rajasthan, is now EU GMP certified by the National Organisation for Medicines, Athens - Greece!
Medicamen Biotech’s Bhiwadi Manufacturing Facility achieves European Union GMP Approval from MOH, Greece.
Our state-of-the-art manufacturing facility at Bhiwadi, Rajasthan, is now EU GMP certified by the National Organisation for Medicines, Athens - Greece!
USFDA Approval
Shivalik Rasayan Ltd., the parent company of Medicamen Biotech Ltd., has successfully received USFDA approval for its state-of-the-art global API manufacturing facility.
Shivalik Rasayan Ltd., the parent company of Medicamen Biotech Ltd., has successfully received USFDA approval for its state-of-the-art global API manufacturing facility.