Regulatory | 19 March 2024
Carbogen Amcis (Shanghai) completed ANVISA Audit
A five-day inspection was concluded successfully with no critical and no major observations raised
A five-day inspection was concluded successfully with no critical and no major observations raised
Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
The company is confident of addressing the concern raised by the USFDA
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
These approvals mark significant progress for Venus Remedies in expanding its market presence
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
The validations confirm the completion of the applications and commence the scientific review process
The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
The product will be launched in March 2024
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series
The observations do not pose any risk to site's compliance standards or its business continuity
Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies
Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA
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