IPP Bureau
Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
By IPP Bureau - January 18, 2025
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution
By IPP Bureau - January 18, 2025
Hyper-automated AI is a unified framework combining AI, ML, RPA, and NLQ to streamline data extraction, quality management, transformation, and actionable insights - all on a single platform
Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
By IPP Bureau - January 18, 2025
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Calquence combination approved in US for untreated mantle cell lymphoma
By IPP Bureau - January 18, 2025
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
AstraZeneca receives CDSCO approval to launch eculizumab in India
By IPP Bureau - January 17, 2025
Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome
Bajaj Healthcare receives exclusive rights for manufacturing, distribution & sales of finished formulation of Magnesium L Threonate
By IPP Bureau - January 17, 2025
The brand Magtein by Threotech has a sales value of approximately US $438 million
FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
By IPP Bureau - January 17, 2025
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Sun Pharma to acquire 100% stake in Antibe Therapeutics
By IPP Bureau - January 17, 2025
Antibe Therapeutics is a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation
AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma
By IPP Bureau - January 17, 2025
SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3
Alleima completes the acquisition of medical components firm Endox
By IPP Bureau - January 16, 2025
In 2023, Endox had revenues of approximately SEK 65 million
Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences
By IPP Bureau - January 16, 2025
With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader
Alembic announces USFDA final approval for Brexpiprazole Tablets
By IPP Bureau - January 16, 2025
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
By IPP Bureau - January 16, 2025
Morepen Laboratories approves hiving off of medical devices business
USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
By IPP Bureau - January 16, 2025
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
atulya launches winter essential kit for hair and skin care
By IPP Bureau - January 16, 2025
atulya keratin & wheat protein shampoo has force of natural ingredients like extract of wheat, fenugreek, reetha & almond oil
