USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
The observations issued are neither repeated observations nor related to data integrity
The observations issued are neither repeated observations nor related to data integrity
This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
VaxiFlu-4 is being marketed by Zydus Vaxxicare-a division of the group focussing on preventives
The Formulation & Technology Centre intends to function as a technology storefront, offering advanced formulation and processing solutions to address the growing demand for complex drug formulations
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
This innovative platform is strategically essential to developing and scaling high-value life sciences use cases such as streamlining the content supply chain
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
Among those identified, 2.4 lakh patients have been notified from public health institutions, while 1.1 lakh were identified through private healthcare facilities
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