IPP Bureau
USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
By IPP Bureau - February 24, 2021
The company will review FDA's response and decide on appropriate next steps soon.
Thermo Fisher’s new facility in Bengaluru to produce reliable COVID-19 testing kits
By IPP Bureau - February 23, 2021
Applied Biosystems CoviPath COVID-19 RT-PCR Kit is approved for in vitro diagnostic use by ICMR and DCGI.
“Minus 20°C is sometimes trickier than minus 70°C”
By IPP Bureau - February 22, 2021
DHL and other logistics companies were already transporting pharmaceutical products at minus 70°C in Schaumaplast boxes packed with dry ice before the coronavirus pandemic
Unichem Laboratories receives ANDA approval for Apremilast Tablets
By IPP Bureau - February 20, 2021
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .
Zydus Cadila receives final approval from USFDA for Droxidopa capsules
By IPP Bureau - February 20, 2021
It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.
Lupin receives approval for Droxidopa capsules
By IPP Bureau - February 20, 2021
Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness
Dr. Reddy's initiates process for emergency use authorization of Sputnik V
By IPP Bureau - February 20, 2021
Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 2pt February 2021.
Dr. Reddy's Laboratories launches FH Tablets in the U.S. Market
By IPP Bureau - February 19, 2021
Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.
Granules India announces approval of Potassium Chloride ER Capsules
By IPP Bureau - February 18, 2021
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
Lupin launches posaconazole delayed-release tablets
By IPP Bureau - February 18, 2021
posaconazole delayed-release tablets 100 mg are the generic equivalent of Noxafil.
Steady quarter with margin improvement for Glenmark: ICICI Securities
By IPP Bureau - February 17, 2021
India business grew 11.8% YoY vs mid-single digit industry growth.
Glenmark Q3 FY21 net profit up 30% at Rs 248 Cr
By IPP Bureau - February 15, 2021
The jump in profit is due to the better performance of the API business.
Steady performance; for Alkem Laboratories: ICICI Securities
By IPP Bureau - February 13, 2021
The company continued to maintain clear FDA status across its plants and has received 12 ANDA approvals during 9MFY21
Jubilant Pharmova recovers: ICICI Securities
By IPP Bureau - February 13, 2021
Jubilant announced the completion of demerger of pharma and LSI business into two separate companies
Approval accorded under PLI Scheme for domestic manufacturing of medical devices
By IPP Bureau - February 12, 2021
The medical device Sector in India suffers from a considerable cost of manufacturing disability.
