FDA FORM
Biocon gets EIR from USFDA for manufacturing facility in BengaluruBiocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good man...
- NCBS scientists identify 33 molecules that could be used to treat virus patients
A group of scientists led by Professor R. Sowdhamini at NCBS has identified the 33 small molecules from a database of over 3,30,000 small m...
- Plan to approach USFDA for re-inspection of key plants in next few months: Lupin
The US drug regulator, after inspecting the two sites, had expressed concerns over quality-control procedures that include handling of out-...
- Startups race to develop tech that can clear workplaces of Covid
In the spring, the Smithfield plant in Sioux Falls became the number one virus hotspot in America, with a cluster of 644 confirmed cases am...
- Alembic Pharma receives 4 observations from USFDA for Panelav facility
"The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility...
- Biocon gets 3 USFDA observations for insulin facility in Malaysia
USFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargi...
- Biocon shares fall as USFDA issues Form 483 for Bengaluru facility
Biocon said that the observations are procedural in nature.
- USFDA issues 2 observations after inspection of Lupin's Pithampur unit
The inspection of the company's Pithampur Unit-I facility by the USFDA has been completed.
- Dr Reddy's gets FDA nod for 'Tosymra' migraine nasal spray
The drug maker said the audit of its API manufacturing plant at Miryalaguda in Telangana, by the US FDA, has been completed.
- USFDA inspection of Biocon's drug substance unit at Bengaluru complete
The week-long audit concluded without any observations and no Form 483 was issued, it added.
- Scientists identify drugs that may block coronavirus from jumping to uninfected cells
They said sometimes this hijacking interferes with the activity of the host's proteins and other important molecules such as enzymes, which...
- Indoco Remedies receives EIR from USFDA
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
- USFDA finds several violations in Aurobindo sterile injections unit
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility managem...
- India's drug regulator grants Gilead Sciences marketing authorisation for remdesivir
The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the cor...
- Inspection of Unichem's Kolhapur facility by USFDA completed without observations
The inspection was a CGMP surveillance and pre-approval inspection and was successfully concluded without any FDA Form 483 issued.
- USFDA concludes inspection of Unichem Lab's Roha facility
The inspection was a post-approval inspection and successfully concluded.
- ‘We will ensure Remdesivir supply when India wants it’
Hyderabad based generic pharmaceutical company Hetero Labs is working on a “war footing” to make remdesivir available for Covid-19 patients...
- USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility
As per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditi...
- Sun Pharma receives 483 for Baska facility, co says responded to USFDA
At the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to...
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