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NATCO PHARMA USFDA
Natco Pharma, 3 other pharma stocks decline up to 2.5% after important inspections at their units. Do you own?Indian pharmaceutical stocks, including Lupin, Shilpa Medicare, and Natco Pharma, are under scrutiny following recent USFDA inspections at ...- USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad divisionNatco Pharma announced that its Hyderabad-based pharma division received a Form 483 with seven observations from the USFDA following an ins...
- Natco Pharma gets warning letter from USFDA for Telangana plantNatco Pharma, a pharmaceutical company, received a warning letter from the USFDA regarding its manufacturing plant in Telangana. This came ...
- Eli Lilly buckles under pressure, offers voluntary licence to Natco PharmaLily has issued voluntary licenses for Barcitinib to six Indian drug makers besides Natco, these include- Sun Pharma, Cipla, Dr Reddy's, Lu...
- Eli Lilly inks pacts for Baricitinib with Sun Pharma, Cipla, Lupin for COVID-19 treatment in IndiaAs the threat of compulsory licence (CL) looms over big pharma in India, companies are rushing in to sign voluntary licensing agreements th...
- Natco's marketing partner gets USFDA nod for cancer treatment drug"Breckenridge Pharmaceutical Inc (BPI) has received final approval for its abbreviated new drug application (ANDA) for Everolimus tablets f...
- Natco Pharma's marketing partner gets USFDA nod for cancer treatment drug"Breckenridge Pharmaceutical Inc. has received final approval for its abbreviated new drug application (ANDA) for Pomalidomide Capsules fro...
- Natco Pharma gets USFDA approval for Visakhapatnam facilityHyderabad-based Natco Pharma Ltd on Tuesday said it has received the final approval from the US health regulator for its first supplemental...
- Natco Pharma gets EIR from USFDA for Telangana facilityThe United States Food and Drug Administration (USFDA) had conducted pre-approval inspection at the company's drug formulations facility in...
- USFDA issues 6 observations to Natco Pharma's API facility near HyderabadThe United States Food and Drug Administration (USFDA) conducted inspection at Kothur facility between August 5-9, 2019.
- USFDA issues 9 observations to Natco Pharma's Kothur facility"At the end of the inspection, the facility received 9 observations, with no repeat observations and mostly procedural in nature," Natco Ph...
- USFDA makes 6 observations at Natco Pharma's Kothur facilityNatco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observ...
- Natco Pharma gets USFDA nod for Armodafinil tabletsNatco Pharma has received final approval from the US Food and Drug Administration (USFDA) for generic version of Armodafinil tablets.
- Natco Pharma gets USFDA nod for generic Budesonide capsulesThe company has received "final approval of abbreviated new drug application from the US Food and Drug Administration for generic version o...
- Natco Pharma gets EIR from USFDA for Kothur facilityKothur facility predominantly caters to regulated international markets. EIR is given after the completion of the inspection by the USFDA.
- Natco will out-license molecules to big pharma: Amit Rajan, Director, Celogen LifeAmit Rajan, Director, Celogen Life says that Micro Labs will quickly come out of the FDA and midcap space as they have a good R&D pipeline.
- USFDA observations on 2 units not to impact products: Natco"The company has received 483 observations for both facilities and believes them to be of minor in nature," a statement said.
- Natco Pharma's US partner Mylan files application with USFDANatco Pharma's marketing partner Mylan Inc has filed an application with the US health regulator for generic Sorafenib tablets used mainly ...
- Natco Pharma's US partner gets FDA nod for wakefulness tabletsBreckenridge had filed its abbreviated new drug application (ANDA) with a Paragraph IV certification to obtain approval to manufacture.
- Lupin, Natco tie up to market breast cancer tabletsDrug firms Lupin Ltd and Natco Pharma today said that they have entered into an alliance to jointly market generic Lapatinib Ditosylate tab...
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