Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure
This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery
The products will be manufactured in Goa India and marketed & distributed in Australian markets
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Aims to achieve CDMO sales of US$ 400 million by 2028
The recent inspection covered both cGMP and PAI processes
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