This milestone highlights a closely integrated development-to-submission model: Orbicular led the product development and technical program for this complex peptide, while OneSource supported the program as the CDMO partner, providing end-to-end manufacturing capabilities for the U.S. market filing. The collaboration is designed to ensure a reliable commercial supply from OneSource’s US-FDA-approved flagship site in Bangalore.

Neeraj Sharma, CEO & MD, OneSource Specialty Pharma Limited, speaking on the development, said: “We are pleased to announce that our partner Orbicular, along with its front-end partner (the ANDA holder), has received tentative approval for a generic version of Ozempic® (Semaglutide Injection). This milestone reflects Orbicular’s scientific expertise and OneSource’s COMO capabilities, supported by our US-FDA approved manufacturing site.”

OneSource continues to strengthen its position as a global CDMO partner for drug-device combinations, complex injectables, and specialty pharmaceutical products through strategic collaborations such as the one with Orbicular, where OneSource serves as the CDMO partner supporting manufacturing and commercial supply readiness.

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There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.

With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site.

The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules’ Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing.

“We plan on launching the product into the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval,” said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited. “We also have other products filed from this site and expect the U.S. FDA to approve them following necessary audits if required. This marks the first approval from our second Hyderabad facility with finished dosage capabilities.”

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PUNE: A team of doctors at KEM Hospital, Pune successfully conducted a Piccolo Device Closure procedure on a 23-week-old baby (male) with Patent ductus arteriosus (PDA) condition. The Piccolo Device Closure procedure and that too on a 23-week baby is the first in Pune. The multi-departmental treatment was led by Paediatric Cardiologist Dr. Pankaj Sugaonkar and Senior Neonatologist Dr.Tushar Parikh. Survival of a 23-week premature baby in itself is rare; reported from Pune only once previously in 2018 by the same team at KEM Hospital Pune, led by Dr.Tushar Parikh. The hour-long procedure performed in the cath lab and led by experts was assisted by a team of neonatologists, sisters, and cath lab technicians.

Explaining the case Dr. Tushar Parikh, Senior Neonatologist at KEM Hospital, Pune said that the premature baby was in critical condition when born. As a part of our NICU procedure for such babies, we conduct point-of-care functional eco-cardiography. This is done to find out the cardio-vascular adaptation of the babies. The baby was diagnosed with Patent ductus arteriosus (PDA).

PDA is a congenital heart defect where there is a persistent opening between two major blood vessels. An opening called the ductus arteriosus is part of a baby’s blood flow system in the womb. It usually closes shortly after birth. If it remains open, it’s called a patent ductus arteriosus. A large opening if untreated can result in many complications.

Dr. Parikh added that in such cases we give a standard dose of medicines. However, the opening between the two blood vessels could not be closed. This was causing excess blood load on the lungs and the baby was ventilator-dependent for about one and a half months. We were just not able to get the baby off-ventilator due to this heart condition. After counseling the parents, we decided to go for the Piccolo Device Closure procedure. The weight of the baby had also increased from about 586 gm when born to 1600 gm during this time.

Dr. Pankaj Sugaonkar, Consultant Paediatric Cardiologist at KEM Hospital, Pune said that in this case, since the medicines were unable to close the opening the only option was surgery. Before Piccolo Device, heart surgeries were the only option to close this opening where incisions are made from the back side between the ribs. But in this case, the condition of the baby was extremely critical and challenging. The baby was constantly on ventilatory support and not stable for surgery. The innovative Piccolo Device Procedure is a boon for such babies and was lifesaving in this case.

Dr Sugaonkar added that the procedure is performed in a cath lab. The device is in the form of three disc-shaped or dumbbell-shaped layers made of metal. It is loaded in a delivery system and inserted through a small 3mm incision at the inguinal region and guided through vessels to the heart to seal the opening. To help this happen catheter and a sheath in a crossed manner are guided through the vessel on which the device is placed and taken on the descending thoracic aorta after which the device is taken to seal the opening. ‘ In an extremely premature neonate it all becomes very challenging’ he added.

In six to nine months, a tissue layer grows over the device and becomes part of the heart. This is a one-time procedure and the device need not be changed, nor are any medications required. The procedure has many advantages. Lesser surgical marks, lower risk of infection, and faster recovery make this procedure more viable in such critical cases.

The baby is now 10 months old and doing fine added Dr. Parikh. We are happy to see the baby doing fine. His regular follow-up echo showed the device was in place and the baby’s gaining weight, added Dr. Sugaonkar

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