US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
This Bioforum will provide the latest insights on delivering increased speed, greater flexibility and enhanced quality while reducing the cost, and risks of navigating the evolving biopharma landscape
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
3D CMOS chip for connecting electroactive tissues and organoids to software
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
This rapid analytical technique provides additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs)
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
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