IPP Bureau

Briefs: Neuland Laboratories, Cipla and Zydus
Briefs: Neuland Laboratories, Cipla and Zydus

By IPP Bureau - February 20, 2023

Cipla has received 8 inspectional observations in Form 483

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

By IPP Bureau - February 20, 2023

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States

India achieves 15,000+ transplants in a year
India achieves 15,000+ transplants in a year

By IPP Bureau - February 20, 2023

There is a fast resurgence in the transplant activities post COVID

Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado
Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado

By IPP Bureau - February 19, 2023

Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability

Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Merck and AstraZeneca present final results from Phase 3 PROpel Trial

By IPP Bureau - February 18, 2023

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival

USFDA accepts for priority review the sNDA for Merck’s Prevymis
USFDA accepts for priority review the sNDA for Merck’s Prevymis

By IPP Bureau - February 18, 2023

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

IAGES collaborates with technology leaders in robotic surgery
IAGES collaborates with technology leaders in robotic surgery

By IPP Bureau - February 18, 2023

IAGES to focus on upskilling and adoption of advanced Minimal Access Surgery technologies in 2023

Garuda Aerospace and Narayana Health join hands to transport biomedical supplies using drone
Garuda Aerospace and Narayana Health join hands to transport biomedical supplies using drone

By IPP Bureau - February 18, 2023

The partnership is announced at Aero India 2023, Bangalore

Pfizer announces Talzenna and Xtandi combination data from phase 3 study
Pfizer announces Talzenna and Xtandi combination data from phase 3 study

By IPP Bureau - February 18, 2023

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI

Asahi Kasei completes construction of microcrystalline cellulose plant
Asahi Kasei completes construction of microcrystalline cellulose plant

By IPP Bureau - February 18, 2023

With the new facility, the company underlines its commitment to meet the substantially growing demand for its MCC

Patient care is an imperative dimension in providing quality healthcare: Dr. Bharati Pravin Pawar
Patient care is an imperative dimension in providing quality healthcare: Dr. Bharati Pravin Pawar

By IPP Bureau - February 18, 2023

The workshop strived to sensitize states and various stakeholder departments regarding their role in the implementation of National Patient Safety Implementation Framework, as well as augment capacity building of health care professionals

Dr. Mandaviya hails eSanjeevani milestone of providing telemedicine services to 10 Cr patients
Dr. Mandaviya hails eSanjeevani milestone of providing telemedicine services to 10 Cr patients

By IPP Bureau - February 18, 2023

eSanjeevani 2.0 will enhance the telemedicine experience further with a plethora of new features both in terms of technology as well as innovation

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg
Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

By IPP Bureau - February 18, 2023

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)

Lupin receives EIR from USFDA for injectable facility in Nagpur
Lupin receives EIR from USFDA for injectable facility in Nagpur

By IPP Bureau - February 18, 2023

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

By IPP Bureau - February 18, 2023

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million

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