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Dr. Mansukh Mandaviya and Bhagwanth Khuba to grace Silver Jubilee function of NPPA
News | August 29, 2022

Dr. Mansukh Mandaviya and Bhagwanth Khuba to grace Silver Jubilee function of NPPA

To mark the occasion, Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0), an integrated responsive cloud-based application developed by NPPA with technical support from C-DAC will be launched


Lupin receives tentative approval from USFDA for Dasatinib Tablets
Drug Approval | August 29, 2022

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).


Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
News | August 29, 2022

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.


USFDA completes inspection at Aurolife Pharma’s Raleigh unit
Drug Approval | August 29, 2022

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.


Qdenga approved in Indonesia for use regardless of prior dengue exposure
Drug Approval | August 28, 2022

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age


Moderna files for emergency use of BA.4/BA.5 Omicron booster
Biotech | August 28, 2022

Moderna files for emergency use of BA.4/BA.5 Omicron booster

Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September


Cipla receives 6 observations from USFDA for Goa facility
Drug Approval | August 28, 2022

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.


Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Drug Approval | August 27, 2022

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).


US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
News | August 26, 2022

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.