IPP Bureau
Lupin receives tentative approval from USFDA for Dasatinib Tablets
By IPP Bureau - August 29, 2022
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
Eiko Lifesciences enters into MOU with Delicare Lifesciences
By IPP Bureau - August 29, 2022
The MOU provides for assistance in the form of efficient working Capital Management, development and commercialisation of new products, logistic supply chain management support etc.
Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
By IPP Bureau - August 29, 2022
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
USFDA completes inspection at Aurolife Pharma’s Raleigh unit
By IPP Bureau - August 29, 2022
The unit has filed 2 Derma products and 1 MDI product.
Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
By IPP Bureau - August 29, 2022
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
SciGenom announces Phd program in collaboration with CHARUSAT University
By IPP Bureau - August 29, 2022
This industry-academia collaboration will provide students with an opportunity to participate in research activities with multiple international universities and scientists
Moderna sues Pfizer, BioNTech for mRNA patent infringement
By IPP Bureau - August 28, 2022
Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016
Qdenga approved in Indonesia for use regardless of prior dengue exposure
By IPP Bureau - August 28, 2022
Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age
Novartis to spin-off Sandoz business to a standalone company
By IPP Bureau - August 28, 2022
Sandoz is planned to be incorporated in Switzerland and to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US
Moderna files for emergency use of BA.4/BA.5 Omicron booster
By IPP Bureau - August 28, 2022
Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September
Collective efforts needed to make India a global healthcare leader: Dr Mandaviya
By IPP Bureau - August 28, 2022
It is high time that India assumed a leadership role in healthcare.
Philips spotlights integrated, data-driven cardiology solutions at ESC 2022
By IPP Bureau - August 28, 2022
Philips AI-powered interventional and diagnostic smart systems enhances diagnostic confidence, drive greater efficiency, and improve patient outcomes
Glenmark receives OAI from USFDA for Goa facility
By IPP Bureau - August 28, 2022
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
Cipla receives 6 observations from USFDA for Goa facility
By IPP Bureau - August 28, 2022
There are no data integrity (DI) observations.
Syngene International forms a new subsidiary
By IPP Bureau - August 28, 2022
The company shall be engaged in the business of manufacturing of pharmaceutical, bio-pharmaceutical and biological products of any kind
