IPP Bureau

Lupin launches Mirabegron Extended-Release Tablets in US
Lupin launches Mirabegron Extended-Release Tablets in US

By IPP Bureau - April 22, 2024

Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US

Biocon receives approval from SAHPRA for Tacrolimus Capsule
Biocon receives approval from SAHPRA for Tacrolimus Capsule

By IPP Bureau - April 22, 2024

Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

By IPP Bureau - April 22, 2024

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A

Evotech and Variant Bio partner to develop fibrosis treatment
Evotech and Variant Bio partner to develop fibrosis treatment

By IPP Bureau - April 22, 2024

Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program

Boehringer Ingelheim introduces NexGard Spectra for dogs in India
Boehringer Ingelheim introduces NexGard Spectra for dogs in India

By IPP Bureau - April 22, 2024

NexGard Spectra is a soft, flavourful monthly chew that kills fleas before they can lay eggs

Orexo extends patent protection for its nasal epinephrine powder product OX640 in the US
Orexo extends patent protection for its nasal epinephrine powder product OX640 in the US

By IPP Bureau - April 22, 2024

The newly issued patent, US Patent No. 11,957,647, provides both expanded scope of protection as well as longer patent term

Zydus launches Mirabegron ER Tablets in the US
Zydus launches Mirabegron ER Tablets in the US

By IPP Bureau - April 22, 2024

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market

Marksans Pharma updates on USFDA inspection at Verna, Goa manufacturing facility
Marksans Pharma updates on USFDA inspection at Verna, Goa manufacturing facility

By IPP Bureau - April 22, 2024

Akums launches Bharosa campaign
Akums launches Bharosa campaign

By IPP Bureau - April 22, 2024

The campaign marks an important milestone in its journey within the pharmaceutical manufacturing industry

Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification
Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

By IPP Bureau - April 22, 2024

Roche gets FDA approval for Alecensa in early lung cancer
Roche gets FDA approval for Alecensa in early lung cancer

By IPP Bureau - April 22, 2024

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy

Vertex announces advancements of Suzetrigine in acute and neuropathic pain
Vertex announces advancements of Suzetrigine in acute and neuropathic pain

By IPP Bureau - April 22, 2024

Breakthrough Therapy designation for pain associated with DPN granted by FDA

Jubilant Pharmova to close manufacturing operations of Solid dosage formulation facility of Jubilant Cadista USA
Jubilant Pharmova to close manufacturing operations of Solid dosage formulation facility of Jubilant Cadista USA

By IPP Bureau - April 19, 2024

The US Generics market has been witnessing significant pricing pressure leading to significant losses at Jubilant Cadista since FY2022 onwards.

Shilpa Medicare launches Pemetrexed injection
Shilpa Medicare launches Pemetrexed injection

By IPP Bureau - April 19, 2024

Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents

Fresenius Kabi USA flies complaint against NATCO Pharma
Fresenius Kabi USA flies complaint against NATCO Pharma

By IPP Bureau - April 19, 2024

Natco Pharma intends to defend the matter accordingly

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