Tag: USFDA

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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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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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%.

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

Cipla Patalganga Unit: CNBC-TV18 accesses the six USFDA observations

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

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CNBC-TV18 has managed to access the six observations that the United States Food and Drug Administration (USFDA) issued for Cipla Ltd.’s Patalganga unit. The observations range from cleanliness to equipment qualification procedures.

The US drug regulator had issued a form 483 with six observations to Cipla’s Patalganga unit last week after conducting a current Good Manufacturing Practices (cGMP) inspection between March 28 to April 4, 2024.

Here are the six observations issued by the USFDA:

• Failure to clean and maintain equipment to prevent contamination
• Equipment and utensils are not cleaned and maintained
• Failure to adequately investigate out of specification results
• Equipment qualification procedures not followed
• Failure to ensure all production deviations are reported and evaluated
• Responsibilities and procedures on quality control not fully followed

Cipla had said that it will work closely with the USFDA and is committed to address these observations within the stipulated timeframe.

Cipla’s Patalganga plant manufactures both Active Pharmaceutical Ingredients (APIs), which are the key raw materials for medicines, as well as formulations.

Shares of Cipla ended 1% lower on Tuesday at ₹1,449. The stock has risen 60% over the last 12 months. The stock has declined in five out of the last six trading sessions.

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

US federal court orders Philips to restrict production of sleep apnea devices

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

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A US federal court issued a decree to restrict the production and sale of Philips’ new sleep apnea machines at several facilities in the country, the Food and Drug Administration said on Tuesday.

The US District Court for the Western District of Pennsylvania has entered into what is known as a consent decree against the company’s subsidiary Philips Respironics to curb the sale and production until certain requirements are met.

In January, the Dutch health technology company had said that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the FDA.

The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.

The decree also requires implementation of a recall remediation plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall.

The plan outlines remediation options such as a new or reworked device for the patients with the option for partial refund of certain devices.

As part of this plan, Philips is also required to make several attempts to contact a patient or a medical equipment provider regarding actions they must take to help ensure patients receive remediation in a timely manner.

Almost the whole of the company’s actionable registered sleep therapy devices have been remediated globally, Philips told Reuters, adding that it will retain experts to review aspects of the remediation.

The company said it will continue to provide new sleep and respiratory care devices outside the United States as the consent decree allows for exports.

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

Granules India’s US subsidiary classified as ‘Voluntary Action Indicated’ by USFDA; shares up

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

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Granules India Ltd on Wednesday announced that the United States Food and Drug Administration (USFDA) has 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.

This classification specifies that the US health regulator will neither take nor recommend regulatory or enforcement action on Granules Pharmaceuticals Inc, as the observations do not meet the threshold for action at the indicated time.

Last year, on December 16, 2023, the USFDA issued a Form 483 outlining a total of five observations to Granules Pharmaceuticals’ plant located at Chantilly, Virginia.

A Form 483 generally carries a list of observations made during the inspection. It is issued by the USFDA inspectors on the completion of the inspection. The inspector communicates and explains these observations to the supplier during the closing conference.

However, the issuance of Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance. After Form 483 is issued, the company is given 15 days for the submission of its response to the USFDA, explaining the steps taken by the company to resolve the in-focus observations made by the health regulatory body.

Granules India shares were trading 1.73% higher at ₹453 per piece on the NSE at 3:21 PM.

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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

Wockhardt to use QIP funds to pare debt

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

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Habil F Khorakiwala, Chairman, Wockhardt says the company will use the proceeds of the recent qualified institutional placement (QIP) to pare debt of ₹100-110 crore and to conduct phase three clinical trials for a new antibiotic, WCK 5222.

Funds managed by veteran investors Madhusudan Kela and Prashant Jain are among the institutions that invested in the QIP. The drugmaker approved the closure of the institutional share sale on March 26, raising ₹480 crore.

As part of the placement, Wockhardt issued 92.85 lakh equity shares at an issue price of ₹517 per share, representing a 5% discount to the QIP floor price of ₹544.02 per share.

Khorakiwala said the clinical trial for WCK 5222 is expected to be completed by next year. The company will file for approval in other markets. “We expect the approval to come sometime in early 2026,” he said.

The global pharmaceutical and biotechnology company reported a 7% growth in net sales to ₹2,124 crore in April-December 2023.

The earnings before interest, taxes, depreciation and amortisation showed a staggering 80% year-on-year (YoY) growth to ₹173 crore in the period under review.

Wockhardt’s growth trajectory in the last three years has been led by vaccines and novel drug discovery of WCK 5222, Nafithromycin, and Emrok. Demands for diabetes biosimilars for India and emerging markets also contributed to the company’s consolidated position in the market.

A total of six programmes of Wockhardt have received Qualified Infectious Disease Product (QIDP) status from the United States Food and Drug Administration (USFDA). These are eligible for a fast-track development process and priority review.

The current market capitalisation of the company is ₹8,951.33 crore.

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

US lawmaker questions FDA for no inspection of Musk’s Neuralink

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

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A US lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.

Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than a month after the startup said it was cleared to test its brain implants in humans.

Neuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip which enables paralyzed patients to control a computer using only their thoughts.

In a letter to the FDA on Monday, Democratic US Representative Earl Blumenauer said he was concerned the agency ignored “troubling evidence” of animal testing violations that had been raised dating back to at least 2019.

Blumenauer also cited reports by Reuters since late 2022 that described employees’ complaints of “hack jobs” of animal experiments due to a rushed schedule, causing needless suffering and deaths. Employees also worried that data quality would be compromised, the media organization reported at the time. He asked the FDA to explain how it reconciled reports of such lapses with its decision to authorize Neuralink’s human trial.

“These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials,” wrote Blumenauer, who serves on the House Ways and Means subcommittee on health.

In response to queries from Reuters about the letter, the FDA said it would respond to the lawmaker directly. The agency also said it routinely carries out inspections after a human trial is approved. When it inspected Neuralink, the FDA said it did not find violations that would undermine the safety of the trial.

Neuralink did not immediately respond to questions.

In recent years, a handful of device companies have begun testing such brain implants in humans, including Synchron and Blackrock Neurotech, who have both demonstrated the ability of patients to control certain actions with their thoughts.

Last week, Neuralink presented a livestream on Musk’s social media platform X, showing how the first patient implanted with its brain device was able to play online chess using his mind. Noland Arbaugh, a 29-year-old who was paralyzed below the shoulders after a diving accident, also posted a comment on X by relaying his thoughts.

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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

Neuland Laboratories Hyderabad unit gets USFDA clearance

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

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Shares of Neuland Laboratories are trading with gains of 6% on Friday, extending its weekly gains to over 8%.

The company informed the exchanges that the USFDA inspection of its Bonathapally unit in Hyderabad was completed successfully with no observations issued under form 483. Neuland made this announcement in an exchange filing

Neuland’s Hynderbad unit was inspected by the US drug regulator from March 18 to March 22 this year.

The company’s Bonathapally unit is an API manufacturing unit with an overall capacity of 233 KL. The facility also boasts of an hydrogenation reaction volume of 7.4 KL and a solvent recovery system of 100 KL per day.

Based on the December quarter shareholding pattern, domestic Mutual Funds own a 1.83% stake in the company, while Alternate Investment Funds have a 4.19% stake. Among these, Malabar Value Fund has a 1.63% stake.

Malabar India Fund has a 9.95% stake as well.

Among prominent public shareholders include Kedia Securities, with a 1.25% stake and Mukul Agrawal, who has a 3.12% stake.

Shares of Neuland Laboratories are trading 6% higher at ₹6,392. The stock has gained nearly 300% over the last 12 months.

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