IPP Bureau

Caplin Point receives EIR from FDA with Zero 483 observations
Caplin Point receives EIR from FDA with Zero 483 observations

By IPP Bureau - January 07, 2025

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

By IPP Bureau - January 07, 2025

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A

Sai Ramana Ponugoti appointed as CEO, ICH of Piramal Pharma
Sai Ramana Ponugoti appointed as CEO, ICH of Piramal Pharma

By IPP Bureau - January 07, 2025

Consequent to this appointment, Sarosh Shetty ceases to be Interim CEO of ICH.

Quality not just a measure, a way of life that drives innovation:  Renewable Energy Minister Joshi
Quality not just a measure, a way of life that drives innovation: Renewable Energy Minister Joshi

By IPP Bureau - January 07, 2025

The cornerstone of the quality ecosystem is the implementation of the Quality Control Orders

1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign
1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign

By IPP Bureau - January 07, 2025

Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

By IPP Bureau - January 07, 2025

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

By IPP Bureau - January 07, 2025

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

By IPP Bureau - January 07, 2025

The biosimilar Ustekinumab has been developed and manufactured by the company

Dr. Jitendra Singh announces CSIR's indigenously developed Paracetamol
Dr. Jitendra Singh announces CSIR's indigenously developed Paracetamol

By IPP Bureau - January 06, 2025

40th DSIR Foundation Day celebration marks 16 more technology transfers from CSIR to MSMEs

ICMR detects two cases of HMPV in Karnataka through routine surveillance
ICMR detects two cases of HMPV in Karnataka through routine surveillance

By IPP Bureau - January 06, 2025

ICMR will continue to track trends in HMPV circulation throughout the year

PM Modi lays foundation stone for new building for Central Ayurveda Research Institute in New Delhi
PM Modi lays foundation stone for new building for Central Ayurveda Research Institute in New Delhi

By IPP Bureau - January 06, 2025

2.92 acre facility will combine tradition and innovation, offering new opportunities for holistic healing, specialized clinics, and skill development to be constructed at a cost of around Rs. 185 crore

Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations
Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations

By IPP Bureau - January 06, 2025

He has 29+ years’ comprehensive experience in world-class Formulations and API (for US and EU requirements) mainly related to injectables

Cupid secures Rs. 14.91 crore order from Govt. of Tanzania for supply of male condoms
Cupid secures Rs. 14.91 crore order from Govt. of Tanzania for supply of male condoms

By IPP Bureau - January 05, 2025

The order, part of an international framework agreement is to be executed between February to April, 2025

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia
CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia

By IPP Bureau - January 05, 2025

Wockhardt plans to launch Miqnaf in the Indian market in coming few months

Yatharth Hospital acquires hospital in New Delhi
Yatharth Hospital acquires hospital in New Delhi

By IPP Bureau - January 05, 2025

The acquired hospital is a well-established hospital based out of Model Town, New Delhi

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