DMF Filings & Regulatory Approvals

USA

USFDA Audits: March 2015, March 2017, March 2018

US DMF: Homatropine Methyl bromide, Celecoxib, Atropine Sulfate (Active), Chlorzoxazone, Diethyl Carbamazine Citrate, Nitisinone, Probenecid, Dexketoprofen Trometamol

CEP

Atropine Sulfate, Ketoprofen (Filed & Under Registration), Levofloxacin Hemihydrate

WHO

WHO Geneva Empanelment

EU

EDMF: Dexketoprofen Trometamol, Homatropine Methyl bromide, Atropine Sulfate, Ketorolac Trometamol, Pregabalin, Levofloxacin Hemihydrate

Korea

MFDS: Dexketoprofen, Ketorolac Trometamol

Australia

TGA empaneled (Atropine Sulphate)

Russia

MOH registration (Ketorolac Trometamol) & Dexketoprofen Trometamol

Taiwan

FDA: Homatropine Methyl bromide, Atropine Sulphate, Levofloxacin Hemihydrate

Canada

Ketorolac Trometamol & Atropine Sulfate under registration

ANVISA

Homatropine Methyl Bromide, Ketorolac under registration

Our clients say

SCL Lifesciences' has strong reputation across multiple countries establishes its CDMO services as trusted and widely approved by regulatory authorities. This global acknowledgment highlights SCL Lifesciences as a dependable partner, adept at meeting diverse compliance standards and delivering exceptional service in international markets, making it a top choice in the industry.

Diwanshu Goyal

Marketing Manager

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Shyrose Erendil

Digital Marketing Manager

SCL Lifesciences' proven track record across numerous countries reinforces the credibility of its CDMO services, earning widespread trust and approval from regulatory bodies. This international recognition underscores SCL Lifesciences’ reliability in adhering to varied compliance requirements and consistently delivering outstanding solutions, partner in the global market.

John Erendil

Digital Executive

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