Drug Approval | September 05, 2023
Caplin Steriles receives EIR from US FDA
The inspection classification was determined by the agency as Voluntary Action Indicated
The inspection classification was determined by the agency as Voluntary Action Indicated
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The approval bolsters the company's Mycophenolate Mofetil portfolio
Propranolol LA is a generic equivalent of Inderal LA
Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year / At one-year
KNISS has established a solid foundation of trust in the customers' minds, delivering high quality Products uncompromisingly.
Jupiter has filed its draft herring prospectus (DRHP) with the market regulator in May this year, to float its IPO
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
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