U.S. FDA issues 7 observations to Natco Pharma's formulations unit in Hyderabad
The facility was inspected by the U.S. FDA from June 9-19. On conclusion, the company received seven observations in Form-483, Natco Pharma said on Thursday. The company said it is confident of addressing the observations within the stipulated timeline.
'The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally,' Natco Pharma said.
The U.S. FDA had in April 2024 issued a warning letter to the facility while raising quality concerns. The action followed an inspection and issue of eight observations in October 2023 by the regulator. The company then said the move may result in delay or withholding of pending product approvals from the site.
The facility is for oral solid dosages, including cytotoxic orals; cytotoxic injectables; and pre filled syringes. The focus product categories are oncology, gastroenterology, central nervous system and cardiology.
EOM
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hindu
3 days ago
- The Hindu
US FDA approves Regeneron's blood cancer therapy
Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood cancer called multiple myeloma that has recurred in patients who had received at least four other therapies earlier. Shares of the company rose 2% following the approval. The company said it is "working diligently" to make the therapy, branded Lynozyfic, commercially available as quickly as possible, and has set a wholesale acquisition cost of $470 per 5 mg vial and $18,800 per 200 mg vial. The accelerated approval was based on a mid-stage trial, in which 70% of patients on Lynozyfic saw their cancer shrink or disappear, while 45% achieved a complete disappearance of their cancer. Lynozyfic is a type of drug called monoclonal antibody that works by targeting two proteins - one found on myeloma cells known as BCMA and another one found on immune T-cells called CD3. These so-called "bispecific antibodies" are "paradigm shifting," Andres Sirulnik, Regeneron's clinical development head for hematology, said. Regeneron is exploring moving such drugs to earlier lines of therapy as they can replace many of the existing treatments used as a standard of care, Sirulnik added. Other bispecific antibodies approved for multiple myeloma are Johnson & Johnson's Tecvayli and Pfizer's Elrexfio. Like Elrexfio and Tecvayli, Lynozyfic comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively. Over 36,000 new cases of multiple myeloma are estimated to be diagnosed in the U.S. in 2025, according to the American Cancer Society. Regeneron estimates about 4,000 new cases will be among those who have received four or more lines of treatment.
&w=3840&q=100)
Business Standard
3 days ago
- Business Standard
Stock calls, July 4: Natco Pharma, Sharda Cropchem among top stocks to buy
Stocks to buy: Analyst pick Sharda Cropchem, Monarch Networth Capital and one more share to buy; Check full details Kunal Kamble Mumbai Stock recommendations Sharda Cropchem Sharda Cropchem has given a breakout above its resistance level and closed higher, indicating buyer dominance. The rise in volume during the breakout confirms strong buying interest at current levels. The stock is trading above all major Exponential Moving Averages (EMAs), suggesting a firm positive trend. The RSI, after a brief consolidation, has turned upward, supporting the ongoing price action. Additionally, DI+ trading above DI- signals a bullish stance, while the ADX above both DI lines reflects strength in the upmove. The stock can be accumulated at current levels, with a stop-loss at ₹830 and an upside target of ₹998. Sharda Cropchem: ₹886.90 Stop loss: ₹830 Monarch Networth Capital Monarch Networth has given a breakout from its recent trading range, accompanied by a rise in volume, indicating buyer dominance over sellers. The stock has managed to close above all major EMAs, which suggests the trend remains positive. The RSI is moving higher, supporting the ongoing price action. Additionally, DI+ trading above DI- indicates a bullish bias, while the ADX trading above DI− signals strength in the current upmove. The stock can be accumulated in the range of ₹355–₹372, with a stop-loss at ₹337, for an upside target of ₹391–₹450. Monarch Networth Capital: ₹371.95 Stop Loss: ₹337 Target Price: ₹391/₹450 Natco Pharma Natco Pharma has taken support near the ₹890 level, which previously acted as a strong base from where the stock had rallied up to ₹1,639. Once again, buyers have stepped in at this level, pushing the price higher to ₹973, with the stock now closing above the 9, 21, and 50 EMAs on the weekly timeframe-a sign of emerging bullish momentum. The rise in volume confirms buying interest at current levels. The RSI has crossed above the 50 mark, indicating improving momentum. Additionally, on the weekly chart, DI+ has crossed above DI−, further supporting the positive outlook. The stock can be accumulated on dips toward ₹912, with a stop-loss at ₹840, for an upside target of ₹1,140–₹1,200. Natco Pharma: ₹973.60 Stop Loss: ₹840 Target Price: ₹1140/₹1200
Mint
4 days ago
- Mint
Listeria risk outbreak: FDA sounds alarm, recalls tainted blueberries
The U.S. Food and Drug Administration (FDA) has issued its most serious warning for contaminated organic blueberries. Alma Pak International recalled 400 boxes (12,000 pounds) of berries after routine tests found Listeria monocytogenes, a deadly bacteria. The Georgia-based company shipped the tainted fruit to one customer in North Carolina before catching the problem in June. By July 1, the FDA declared this a "Class I recall" – meaning eating these berries could cause severe sickness or death. The risky blueberries carry lot numbers 13325 G1060 and 13325 G1096. Though the company claims no berries reached grocery stores, the FDA warns everyone to check their freezers and avoid these products completely. Listeria isn't just ordinary food poisoning. It's America's third-deadliest foodborne illness, killing about 260 people yearly. Unlike most bacteria, Listeria grows in refrigerators, making it extra sneaky. Healthy adults might suffer only fever, vomiting, or diarrhea for a few days. But for pregnant women, it can trigger miscarriages or stillbirths. Older adults, newborns, and people with weak immune systems can develop deadly meningitis (brain swelling) or sepsis. Warning signs include intense headaches, stiff necks, confusion, or seizures. If you ate these berries and feel ill, doctors urge immediate medical help, especially if pregnant. This recall comes just weeks after listeria-tainted chicken meals caused 3 deaths and a miscarriage nationwide. This blueberry alert fits a frightening pattern: US food recalls are skyrocketing. In 2024 alone, roughly 300 recalls made 1,400 people sick, hospitalized 487, and killed 19, double 2023's death toll. Recent months saw recalls for shrimp, turkey, and prepared meals like FreshRealm's fettuccine (sold at Kroger and Walmart). While blueberries normally offer health benefits like better blood pressure and reduced inflammation, contaminated ones become dangerous. Experts advise washing produce thoroughly, cleaning fridge surfaces monthly, and monitoring FDA recall updates. As one microbiologist notes: 'Listeria's early symptoms look like regular flu, but delaying treatment can be fatal when it attacks your brain.'
