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Country of origin : India
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upadacitinib

Tablets, extended release (ER) 15 mg, 30 mg, 45 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Rinvoq®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

Manufacturer usually replies in 29 days

upadacitinib

Tablets, extended release (ER) 15 mg, 30 mg, 45 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, EU GMP, Canada
Manufacturer #10897
A pharmaceutical manufacturer based in Asia that is active in 80+ countries selling its products in Europe, North America, Africa, the Middle East, CIS, LATAM, and Asia for 40+ years. The company's production lines are WHO GMP-compliant. The main dosage forms are tablets, capsules, dry syrups, suspensions, and injections. The main therapeutic areas include antifungal, analgesics, and psychotropics.

Manufacturer usually replies in 61 days

upadacitinib

Tablets, extended release (ER) 15 mg, 30 mg, 45 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
India
Manufacturer #16857
A pharmaceutical manufacturer with integrated capabilities in active pharmaceutical ingredients, intermediates, and finished formulations, supplying pharmaceutical products to global partners across key therapy areas such as diabetes, cardiac care, neurology, anti-bacterial and anti-fungal segments. The organisation highlights strong in-house R&D, backward integration into intermediates and APIs, and scalable manufacturing from development to multi-ton commercial output. For quality, the site states that its formulation manufacturing operates in a GMP-compliant facility recognised by major regulators, and specifically lists approvals/recognition including USFDA, EU-GMP, WHO and TGA, supporting reliable international supply of pharmaceutical products.

Manufacturer usually replies in 28 days

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