Shilpa Medicare receives European marketing authorization for Tadalafil Orodispersible Films for erectile dysfunction
Shilpa Medicare has informed in a BSE filing that the Company has received marketing authorization from Portugal, Europe, for Tadalafil Orodispersible Films, 20 mg.
The total Europe market for oral Tadalafil formulations is estimated at about USD 400 million.
"Shilpa Medicare becomes the first company in the World to receive approval for this product as a convenient, patient friendly oral mouth dissolving/dispersing Film formulation. This approval is a hybrid application and Shilpa’s product is bioequivalent to the reference product," it added.
Tadalafil is indicated for the treatment of erectile dysfunction (sometimes called impotence) in adult males.
This approval has come from the Company’s finished dosage form manufacturing facility, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is currently approved by MHRA UK and this is the second approval for a prescription oral mouth dissolving film product in the European/UK regulated markets from the facility.
The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (oral dispersible/dissolving Films and Transdermal Patches).
Medical Dialogues team had earlier reported that Shilpa Medicare's Joint Venture Oncosol (50:50 JV with Liqmeds Lifecare Limited, a Zydus group company and Koana Healthcare Limited, Shilpa Medicare group company) along with its partner Shorla Oncology had announced the US Food and Drug Administration (USFDA) approval of IMKELDI (imatinib oral solution), a oral liquid form of imatinib to treat certain forms of leukemia and other cancers.
Read also: Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments.
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