- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Expect delay in start of royalty from 2 new drugs: SPARC
NEW DELHI: Sun Pharma Advanced Research Company (SPARC) expects further delay in start of royalty income from its two new drug applications, including an eye drop, due to its parent Sun Pharma receiving a warning letter from the US health regulator for its Halol plant.
The company's two new drug applications (NDAs), Xelpros and Elepsia XR, are to be manufactured at Sun Pharma's Halol plant, which has recently received a warning letter from the US food and Drug Administration (USFDA).
"Consequent to above development, the management expects a possible further delay in the projected royalty income for the company from the above mentioned products," Sun Pharma Advanced Research Company (SPARC) said in a regulatory filing.
The company's management is closely monitoring the development and has initiated steps to mitigate the possible adverse impact on the company, it added.
SPARC has already received a complete response letter (CRL) from the USFDA for the two new products. A CRL is a communication from the USFDA that informs companies that an application cannot be approved in its present form.
Sun Pharma Advanced Research Company was demerged from Sun Pharma as a pharma research and drug discovery company in 2007.
The company's two new drug applications (NDAs), Xelpros and Elepsia XR, are to be manufactured at Sun Pharma's Halol plant, which has recently received a warning letter from the US food and Drug Administration (USFDA).
"Consequent to above development, the management expects a possible further delay in the projected royalty income for the company from the above mentioned products," Sun Pharma Advanced Research Company (SPARC) said in a regulatory filing.
The company's management is closely monitoring the development and has initiated steps to mitigate the possible adverse impact on the company, it added.
SPARC has already received a complete response letter (CRL) from the USFDA for the two new products. A CRL is a communication from the USFDA that informs companies that an application cannot be approved in its present form.
Sun Pharma Advanced Research Company was demerged from Sun Pharma as a pharma research and drug discovery company in 2007.
Next Story