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upadacitinib

Tablets, prolonged release (PR) 15 mg, 30 mg, 45 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #16163

As a result of a strategic agreement with a company delivering an attractive high-quality portfolio with European supply, it is a trustworthy B2B partner with more than 30 years of experience in the out-licensing business model. The organization is a reliable commercial partner that takes a customer-centric approach and strives for long-term partnership development to secure market success.

Manufacturer usually replies in 32 days

upadacitinib

Tablets 15 mg, 30 mg, 45 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP
Manufacturer #276
This company is a global manufacturer and distributor of high-quality generic medicines, with a mission to make these medicines accessible to patients worldwide. It operates in several regions, including Europe and Latin America, and emphasizes strong partnerships within the pharmaceutical industry to expand its reach. The company is committed to sustainability and transparency, following Environmental, Social, and Governance (ESG) principles. They regularly engage in major industry events, highlighting their dedication to networking and maintaining a leading position in the market for generic medications.

Manufacturer usually replies in 20 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 10 days

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