Tag: USFDA

Zydus Life receives final USFDA approval to market acne-treating gel

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Zydus Life on Thursday, May 9, said it has received the final approval from the US Food and Drug Administration (USFDA) to market the Dapsone Gel, 7.5%.

The gel is used to treat acne and will be manufactured at the pharma company’s topical manufacturing facility at Changodar in Ahmedabad.

As per the IQVIA MAT March 24, the Dapsone Gel had 7.5% annual sales of $35.8 million in the US.

The company now has a total of 395 approvals and has filed more than 460 ANDAs since the beginning of the filing process in FY2003-04.

On another note, last week, CNBC-TV18 accessed the 10 observations the USFDA had issued for Zydus Life’s Jarod facility. The USFDA had inspected the facility from April 15 to 23. The observations stated that the facility failed to establish procedures to establish purity and quality of products, employees engagid in manufacturing drug product lacked the required training, the sampling plans and test procedures were not followed, among others.

The company had said it will work closely with the USFDA to address and respond to the observations.

Last month, the company also launched a tablet — Mirabegron Extended-Release tablets, 25 mg — in the US market to treat overactive bladder. It is to be manufactured at the pharma’s company’s manufacturing facility in Ahmedabad SEZ.

Zydus Life shares were trading 0.43% lower at ₹1001.3 apiece at 11.55 am. The stcok has gained 63.6% in the past six months and 90.9% in the past year.

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Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

USFDA completes inspection of Cipla’s unit in Maharashtra’s Kurkumbh

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pharma major Cipla on Wednesday said that the United States Food and Drug Administration (USFDA) conducted a routine inspection at its manufacturing facility in Maharashtra which concluded on May 8.

The US health regulator conducted the inspection as a routine current Good Manufacturing Practices (cGMP) at Cipla’s manufacturing unit in Maharashtra’s Kurkumbh from April 29 to May 8.

“The company will work closely with the USFDA and is committed to address this observation comprehensively within stipulated time,” Cipla said in a release.

Cipla’s shares ended flat at ₹1,385.90 per piece on Wednesday. The stock recorded the session’s low of ₹1,375.05 at 1 pm on NSE.

The pharma giant is set to release its financial numbers for the quarter ended on March 31, 2024 (Q4 FY24) later this week.

For the quarter ended on December 31, 2023, Cipla reported a consolidated net profit of ₹1,055.9 crore, marking an impressive rise of 32% on a year-on-year (YoY) basis from ₹801 crore posted in the same quarter last year.

The company’sl revenue made a double-digit growth of 14.6% to ₹6,788.4 crore in the December quarter compared to ₹5,924.5 crore in the corresponding quarter of the previous fiscal year.

Its operating profit margin improved significantly to 26.46% in the third quarter of FY24 as opposed to 24.23% in the year-ago period, and from 25.96% in the preceding quarter.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Dr Reddy’s launches 40 mg doxycycline capsules for skin therapy in US market

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Drug firm Dr Reddy’s Laboratories Ltd on Friday (May 3) said it launched doxycycline capsules, 40 mg in the US market, a therapeutic generic equivalent of ORACEA (doxycycline, USP) capsules.

“Dr Reddy’s Laboratories Ltd, along with its subsidiaries together referred to as “Dr Reddy’s”), today announced its launch of Doxycycline Capsules, 40 mg* in the US market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the US Food and Drug Administration (USFDA),”

The doxycycline capsules, 40 mg, were approved by the US Food and Drug Administration (US FDA) and are supplied in bottle counts of 30. Each capsule contains 26 mg immediate-release pellets and 14 mg delayed-release pellets equivalent to 40 mg of anhydrous doxycycline, USP.

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Earlier…

Last month, Dr Reddy’s Laboratories voluntarily recalled six lots of medication from the US market, indicated to reduce blood phenylalanine (Phe) levels, on account of being subpotent.

The company is recalling affected lots of sapropterin dihydrochloride powder for oral solution 100 mg to the consumer level due to powder discolouration in some packets leading to decreased potency, the Hyderabad-based drug maker said in a regulatory filing.

The issue was discovered during an accelerated stability test in addition to customer complaints, it added. Reduced efficacy of the product would result in elevated Phe levels in patients.

Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures.

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Shares of Dr Reddy’s Laboratories Ltd ended at ₹6,332.85, up by ₹44.55, or 0.71%, on the BSE.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Novo Nordisk and Eli Lilly raise sales projections on the back of weight loss drugs

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Novo Nordisk and Eli Lilly have upgraded their full-year projections owing to sustained robust demand for their weight-loss drugs. Strong sales of Eli Lilly’s GLP-1 drugs, Mounjaro and Zepbound, during the first quarter (CY2024) prompted an upward revision of its annual sales forecast by $2 billion.

Zepbound’s first-quarter sales reached $517.4 million, surpassing estimates of $418 million, while Mounjaro recorded sales of $1.8 billion, slightly below the anticipated $2 billion, likely due to limited supply.

These medications, both containing the chemical compound tirzepatide, have propelled the market value of US drug makers beyond $700 billion, surpassing that of Tesla and Walmart.

Meanwhile, Danish firm Novo Nordisk, with a 28% YoY profit growth in its Q1 earnings to $3.65 billion, now anticipates sales growth between 19% and 27% in local currencies, compared to the previously guided range of 18% to 26%. This growth is largely driven by the success of its blockbuster drugs, Wegovy and Ozempic, with Wegovy sales experiencing a remarkable 107% YoY surge to 9.4 billion Krones.

Novo Nordisk has ramped up its supply of Wegovy in the US by fourfold since December, with approximately 20,000 new US patients starting weekly injections each week. The success of these drugs has propelled Novo Nordisk’s market value to $570 billion, surpassing the entire Danish economy.

GLP-1 drugs have garnered significant attention for their ability to assist patients in shedding up to 20% of their weight. Over 1 million Zepbound prescriptions and approximately 1.75 million for Wegovy have been written in the US since the beginning of 2024, with demand on the rise as the drugs’ applications expand. For instance, Wegovy has received USFDA approval for reducing the risk of cardiovascular diseases in overweight and obese individuals, while Eli Lilly’s Zepbound is under study for treating sleep apnea.

Eli Lilly and Danish competitor Novo Nordisk are racing to increase production in a weight-loss market projected to reach at least $100 billion by the end of the decade.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Exclusive | CNBC-TV18 accesses 10 USFDA observations issued to Zydus Life’s Jarod facility

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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CNBC-TV18 has accessed the 10 observations the US Food and Drug Administration (USFDA) issued for Zydus Life’s Jarod facility.

Last week, Zydus Life had informed the stock exchanges that it had received 10 observations from the USFDA, which had inspected the Jarod facility from April 15 to 23.

Following are the 10 observations accessed by CNBC-TV18:

1) Failed to review unexplained discrepancy in batch distribution
2) Establishing sampling plans and test procedures not followed
3) Procedures to prevent contamination didn’t include adequate validation
4) Procedures to prevent microbio contamination not followed
5) Failed to establish procedures to establish purity and quality of products
6) Aseptic processing areas to monitor environmental conditions are deficient
7) Equipment and utensils not cleaned and maintained properly
8) Employees engaged in manufacturing drug product lack the training required
9) Procedures for cleaning and maintenance of equipment are deficient
10) Appropriate controls over computers are not excercised

“The company will closely work with the USFDA to address and respond to the observations in an expeditious manner,” Zydus Life had informed the stock exchanges last week.

On another note, last month, the pharma company said it had launched a tablet for the treatment of overactive bladder — Mirabegron Extended-Release tablets, 25 mg — in the US market.

“Mirabegron is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency,” the company said in a stock exchange filing.

The tablet will be manufactured at the company’s formulation manufacturing facility in Ahmedabad SEZ in India.

Zydus Life shares were trading 1.34% higher at ₹966.35 apiece at 12.30 pm. The stock has gained 67.63% in the past six months and 87.28% in the past year.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin gets USFDA nod to launch generic tablet to treat overactive bladder

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Lupin Ltd (NSE: LUPIN) has announced the launch of Mirabegron, a generic version of Mybetriq used to treat overactive bladder in the United States, it informed the BSE in a filing late Saturday evening. The announcement from the Mumbai-headquartered pharma major came after it received approval from the United States Food and Drug Administration (USFDA).

Mirabegron is the generic equivalent of Myrbetriq and is manufactured by Astellas Pharma Global Development. Lupin had earlier informed that the product would be manufactured at its facility in Nagpur, India.

Myrbetriq, a prescription medicine, is used in the treatment of an overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. It is also used to treat neurogenic detrusor overactivity (NDO) in children.

According to IQVIA MAT February 2024, Mirabegron had estimated annual sales of $1,019 million in the United States, the company’s exchange filing said.

Lupin’s Executive Director and Global CFO, and Head of Corporate Affairs, Ramesh Swaminathan, expects the pharmaceutical company to clock quarterly US sales in the range of $200–210 million this year, given the lineup of existing and upcoming products. The North American market contributes roughly 37% to Lupin’s sales, while India is around 34%.

Lupin launched the first generic version of Oracea (Doxycycline capsules, 40 mg) on April 9 in the United States. Oracea capsules are used in the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.

Lupin also recently announced the successful closure of inspections by the USFDA at its manufacturing facility located in Vadodara, Gujarat.

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin shares settled nearly 3% lower on Friday, quoting at ₹1,547 apiece on the NSE. So far this year, Lupin stock price has surged nearly 18%, while the one-year gain on the stock is 120%.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Jubilant Pharmova to get its US generics business back to profitability through these measures

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Jubilant Pharmova Ltd., has decided to shut operations of its subsidiary Jubilant Cadista Pharmaceuticals Inc., USA, due to mounting losses. The unit is likely to cease manufacturing operations on June 17, 2024, it said in an exchange filing.

The subsidiary is involved in the manufacturing of tablets and capsules for the US market and has the capacity to serve 1.5 billion doses. Jubilant Pharmova attributed the decision to significant pricing pressure in the US generics market, that led to losses at Jubilant Cadista since financial year 2022. The company did not disclose the quantum of the losses.

However, Jubilant Cadista will continue the sales and marketing operations for the US market. The subsidiary will continue to explore various options to utilise or sell the facility’s land, building, plant and machinery in due course of time.

Jubilant Pharmova has now decided to change the operating model from in-house manufacturing to outsourced manufacturing by selected USFDA-approved Contract Manufacturing Organisations (CMOs) for the US market to get the US generics business back to profitability.

On Wednesday, Jubilant Pharmova’s wholly-owned subsidiary Jubilant Pharma Ltd. said that its subsidiary Jubilant Generics Ltd. (JGL) received a communication from the US drug regulator, which determined the inspection classification of its Roorkee facility as “Voluntary Action Indicated” (VAI).

Based on this classification, the facility is considered to be in “acceptable state of compliance” with regard to current Good Manufacturing Practices (cGMP). The regulator also concluded the inspection as “closed.”

Following this change in status for the Roorkee facility, the company expects exports from this unit to the US market to increase in a meaningful and gradual manner. Currently, the facility exports only one product, Risperidone, to the US market.

“These actions are expected to improve the gross margins of the generics business by reducing manufacturing, quality management and overhead costs, which will drive the generics business towards profitability,” Jubilant Pharmova’s statement state. The generics business also has plans to scale up revenues in the US markets by launching new products.

Shares of Jubilant Pharmova had ended 3.3% higher on Tuesday at ₹672.4. The stock has risen 112% over the last 12 months.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Aurobindo Pharma shares drop amid 3 USFDA observations to company’s Eugia Sterile unit

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Aurobindo Pharma shares dropped more than 2% on Monday after the United States Food and Drug Administration (USFDA) issued Form 483 to the company’s Eugia Sterile unit with three critical observations.

The US drug regulator’s observations come following an inspection conducted at the unit from March 28 to April 5, according to Form 483 accessed by CNBC-TV18.

During the inspection, the USFDA team found shortcomings in key areas of the plant’s operations, raising concerns about the adequacy of procedures to prevent microbiological contamination of drug products.

Additionally, the review highlighted a lack of verification processes for data accuracy and the absence of established control procedures.

Aurobindo Pharma is expected to address these observations promptly to ensure compliance with regulatory requirements and maintain the integrity of its manufacturing operations.

The company’s response to the Form 483 observations will be closely monitored by regulators and industry stakeholders as they work to uphold standards of quality and safety in the pharmaceutical industry.

Earlier this month, Aurobindo Pharma announced that USFDA conducted an inspection of its newly operational injectable facility in Andhra Pradesh from March 28 to April 5. The inspection closed with three observations.

The facility is managed by Eugia Steriles Private Ltd, which is a subsidiary of Eugia Pharma Specialities Ltd which in turn is a step-down subsidiary of Aurobindo Pharma.

Last month, Aurobindo Pharma Ltd announced that it has received final approval from the USFDA to produce and sell mometasone furoate monohydrate nasal spray, 50mcg/spray.

Aurobindo now holds a combined total of 507 ANDA approvals from the USFDA, comprising 488 final approvals and 19 tentative approvals.

Shares of Aurobindo Pharma were trading 0.86% lower at ₹1,078.2 apiece on the BSE at 11:25 am.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Granules India Unit V facility in Andhra Pradesh’s Anakapally gets Zero 483 from USFDA

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pharmaceutical major Granules India announced on Friday, April 12, that its Unit V facility located at Anakapally, Visakhapatnam in Andhra Pradesh, received Zero 483 from the United States Food and Drug Administration (USFDA). The USFDA inspected the facility between April 8 and April 12.

“This audit was a Pre Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs); oncology and non-oncology. The audit resulted in Zero 483’s,” the company informed in an exchange filing.

The Granules India facility manufactures APIs and formulations of oncology and non-oncology products.

Earlier on April 3, the company informed exchanges that the USFDA classified a facility of its subsidiary located in the United States as ‘Voluntary Action Indicated’. The Virginia-based wholly-owned foreign subsidiary of the pharmaceuticals company, Granules Pharmaceuticals Inc. (GPI), has received a VAI classification from the US drug regulator.

What is a Form 483?

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Granules India share price performance

Shares of Granules India ended more than a percent lower on Friday, settling at ₹422 on the NSE. The stock price opened at ₹428 and hit the day’s high at ₹436 and low at ₹420.70. So far this year, Granules India shares have surged 2.48%, while the one-year return on the stock is nearly 42%, higher than the Nifty50 return of over 26%.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Lupin’s Gujarat facility successfully clears USFDA inspection with no observations; stock surges

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Lupin Ltd shares gained over 2% on Friday, after the company announced the successful closure of inspections by the United States Food and Drug Administration (USFDA) at its manufacturing facility located in Vadodara, Gujarat.

In a filing to the stock exchanges, the pharmaceutical company informed that a Good Manufacturing Practice (GMP) inspection has been completed at the company’s API (active pharmaceutical ingredient) manufacturing facility located at Dabhasa in Gujarat.

The US health regulator conducted the GMP inspection from April 8 to April 12, 2024. The inspection has been completed with no observations, the company said in an official release.

“This accomplishment underscores our unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare for all,” said Lupin’s Managing Director, Nilesh Gupta.

Earlier this week, Lupin launched the first generic version of Oracea (doxycycline capsules, 40mg) in the United States after receiving approval from the USFDA.

Doxycycline capsules 40 mg is indicated for the treatment of skin infections like inflammatory lesions (papules and pustules) of rosacea in adult patients.

For the quarter ended on December 31, 2023, Lupin reported a net profit of ₹613.1 crore, making a stellar jump of 299.6% on a year-on-year (YoY) basis from ₹153.4 crore posted in the same quarter last year.

The company’s revenue from operations made a double-digit growth of 20.2% to ₹5,197.4 crore in the December quarter compared to ₹4,322.2 crore in the corresponding quarter of last year.

Its earnings before interest, taxes, depreciation, and amortisation (EBITDA) stood at ₹1,037.9 crore, growing 95% YoY from ₹1,037.9 crore in the year-ago period.

Shares of Lupin closed 1.19% higher at ₹1,624.65 apiece on the BSE on Friday.

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3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow