Central Drugs Standard Control Organisation

Argus Research Initiates Equity Report Coverage on SS Innovations International, Inc. (OTC: SSII)

Retrieved on: 
Monday, October 16, 2023
Pain, Hospital, Perception, Disease, OTC, Leonardo da Vinci, Miniaturization, 3D, Xi, Google Images, OTC Markets Group, Equity, Risk, Report, Intuitive Surgical, Safety, Robotics, Central Drugs Standard Control Organisation, 720p, CDSCO, Argus, Arm, Anatomy, Patient, FDA, Ageing, SS, CT, Growth, Maintenance, Neck, Research, Abdominal ultrasonography, Infection, Surgeon, Lung, Head, MRI, Sale, United Arab Emirates, US FDA, 3D printing, Medical imaging, Medical device, Renewable energy

The platform has been validated in India to perform more than 40 different types of surgical procedures, including cardiac surgery.

Key Points: 
  • The platform has been validated in India to perform more than 40 different types of surgical procedures, including cardiac surgery.
  • In our view, the caliber of SS Innovation's leadership team and investors helps to validate its technology and market prospects.
  • SS Innovations believes that Mantra's unique positioning can address much larger target markets, in terms of patients as well as revenue market sizes.
  • SS Innovations completed its merger with Avra Medical Robotics in April 2023 and trades on the OTC Market under ticker symbol "SSII".

SS Innovations International Sells First SSi Mantra in the Middle East

Retrieved on: 
Wednesday, August 9, 2023
CE, CDSCO, Health, Aster DM Healthcare, Mantra, GCC, Cancer, Head, Sale, Hospital, Patient, SS, Physician, Central Drugs Standard Control Organisation, OTC, FDA, Trauma, Medical device

FORT LAUDERDALE, FL, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of the “SSi Mantra,” a versatile and cost-effective surgical robotic system, today announced that it has filled its first international order. The unit has been delivered to and will be installed in Aster Hospital, one of the premier hospitals in Dubai, United Arab Emirates, which is part operated by Aster DM Healthcare Limited, a publicly-traded multinational for-profit hospital and healthcare that operates 32 hospitals and a network of other healthcare facilities in six countries.

Key Points: 
  • The first international sale of the SSi Mantra was delivered to Dubai, United Arab Emirates
    FORT LAUDERDALE, FL, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of the “SSi Mantra,” a versatile and cost-effective surgical robotic system, today announced that it has filled its first international order.
  • SSi Mantra is the first surgical system to be made in India and one of the only systems in the world that was designed and built to be distinctly cost-effective with broad-spectrum surgical applications.
  • The SSi Team designed its flagship technology, the SSi Mantra Surgical Robotic System, to have many superior and user-friendly features for the entire surgical team.
  • Dr. Sudhir Srivastava, Founder, Chairman and CEO of SS Innovations, said, “We are delighted that the United Arab Emirates Ministry of Health granted SS Innovations the approval for the SSi Mantra system to be imported into the UAE for clinical use.

Bioxytran Initiates a Registrational Trial of Oral ProLectin-M for Mild to Moderate COVID-19 Patients

Retrieved on: 
Tuesday, August 8, 2023
CDSCO, SARS-CoV-2, COVID-19, Clinical trial, Viral, Tablet, Patient, Central Drugs Standard Control Organisation, Political moderate, Escape Room, Viral load, United Kingdom, Virus, Protocol, Pharmaceutical industry, Vaccine

BOSTON, MASSACHUSETTS, Aug. 08, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. ( BIXT ), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced the initiation of a clinical trial to treat Mild to Moderate COVID-19 patients.

Key Points: 
  • BOSTON, MASSACHUSETTS, Aug. 08, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. ( BIXT ), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced the initiation of a clinical trial to treat Mild to Moderate COVID-19 patients.
  • Based on the success of Bioxytran’s Phase 2 trial in mild to moderate COVID-19 patients which achieved a 100% response rate by day 7 versus 6% in placebo the Central Drugs Standard Control Organization (CDSCO) in India approved the clinical trial protocol.
  • The Company is initiating the first stage of its registrational trial which is a dose optimization study that will evaluate 3 different dosage levels against a matching placebo arm in a 5-day trial.
  • Inclusion criteria allows for the recruitment of patients at high risk for progression to severe COVID-19 or patients with a Ct value less than 25.

SS Innovations Begins FDA and CE Regulatory Approval Processes for SSi Mantra Flagship Surgical Robotic Device

Retrieved on: 
Wednesday, August 2, 2023
CE, ELEX, CDSCO, Stryker, Mantra, SSI, Central Drugs Standard Control Organisation, OTC, The Company, FDA, Intuitive Surgical, Medical device

FORT LAUDERDALE, FL, Aug. 02, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic device, the SSi Mantra. The Company has retained Elexes, a regulatory and quality compliance firm, to support the Company as it moves through the approval process.

Key Points: 
  • Company Retains Elexes, a Regulatory and Quality Compliance Firm With Deep Experience, to Advance Approval Process
    FORT LAUDERDALE, FL, Aug. 02, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – SS Innovations International, Inc. (the "Company" or "SS Innovations") (OTC:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic device, the SSi Mantra.
  • The Company has retained Elexes, a regulatory and quality compliance firm, to support the Company as it moves through the approval process.
  • The device has been granted regulatory approval by the Indian Central Drugs Standard Control Organization (CDSCO) and is clinically validated in India in more than 40 different surgical procedures.
  • Dr. Sudhir Srivastava, CEO, Chairman and Founder of SS Innovations, said, "As SS Innovations prepares to pursue regulatory approvals for our SSi Mantra surgical robotic device in Europe and the United States, we are very pleased to have retained Elexes to facilitate the process.

BaroPace Receives Approval for First-in-Human Clinical Trial

Retrieved on: 
Tuesday, July 25, 2023
Medical Devices, Health, Clinical Trials, General Health, Cardiology, Biotechnology, Blood pressure, Feasibility study, Central Drugs Standard Control Organisation, CDSCO, Heart failure, Clinical trial, Exercise, Heart failure with preserved ejection fraction, Hypertension, Patient, Hemodynamics, Heart rate, Safety, Medical device

BaroPace, Inc., a medical technology company dedicated to using blood pressure to regulate pacemakers for patients with heart failure with preserved ejection fraction and hypertension, announced today that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) of India to conduct its clinical trial RelieveHFpEF-II in India.

Key Points: 
  • BaroPace, Inc., a medical technology company dedicated to using blood pressure to regulate pacemakers for patients with heart failure with preserved ejection fraction and hypertension, announced today that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) of India to conduct its clinical trial RelieveHFpEF-II in India.
  • First patient enrollment is expected July 2023.
  • “The relationship between heart rate and blood pressure has been known for 200 years but, until now, pacemakers have been blind to it and other important physiologic parameters,” said Michael Burnam MD , founder and CEO of BaroPace.
  • This is very novel compared to the way pacing rates have been programmed previously.”

Passive Temperature Controlled Packaging Market to Reach $24.4 Billion, Globally, by 2031 at 9.1% CAGR: Allied Market Research

Retrieved on: 
Tuesday, January 31, 2023
Transport, Central Drugs Standard Control Organisation, Temperature, Table, Medicine, PDF, Government, COVID-19, Growth, Vaccine, API, Medication, Chart, Food, Pharmaceutical industry, Retail, Drink

PORTLAND, Ore., Jan. 31, 2023 /PRNewswire/ -- Allied Market Research published a report, titled, "Passive Temperature Controlled Packaging Market by Product Type (Insulated Shippers, and Insulated Containers), Business (Warehousing, and Transportation), and Application (Food and Beverages, Pharmaceuticals, and Others): Global Opportunity Analysis and Industry Forecast, 2022-2031." According to the report, the passive temperature controlled packaging market size was valued at $10,286.1 million in 2021 and is projected to reach $24,462.0 million by 2031, registering a CAGR of 9.1% from 2022 to 2031. The report offers a detailed analysis of changing market trends, top segments, key investment pockets, regional landscapes, and competitive scenarios.

Key Points: 
  • Such factors drives the growth of the global passive temperature controlled packaging market.
  • According to the report, the passive temperature controlled packaging market size was valued at $10,286.1 million in 2021 and is projected to reach $24,462.0 million by 2031, registering a CAGR of 9.1% from 2022 to 2031.
  • Thus, the rise of the above-mentioned industries that extensively use passive temperature controlled packaging is anticipated to drive the growth of the passive temperature controlled packaging market during the forecast period.
  • The passive temperature controlled packaging market was severely hampered during the lockdown period owning to the outbreak of COVID-19.

Passive Temperature Controlled Packaging Market to Reach $24.4 Billion, Globally, by 2031 at 9.1% CAGR: Allied Market Research

Retrieved on: 
Tuesday, January 31, 2023
Transport, Central Drugs Standard Control Organisation, Temperature, Table, Medicine, PDF, Government, COVID-19, Growth, Vaccine, API, Medication, Chart, Food, Pharmaceutical industry, Retail, Drink

PORTLAND, Ore., Jan. 31, 2023 /PRNewswire/ -- Allied Market Research published a report, titled, "Passive Temperature Controlled Packaging Market by Product Type (Insulated Shippers, and Insulated Containers), Business (Warehousing, and Transportation), and Application (Food and Beverages, Pharmaceuticals, and Others): Global Opportunity Analysis and Industry Forecast, 2022-2031." According to the report, the passive temperature controlled packaging market size was valued at $10,286.1 million in 2021 and is projected to reach $24,462.0 million by 2031, registering a CAGR of 9.1% from 2022 to 2031. The report offers a detailed analysis of changing market trends, top segments, key investment pockets, regional landscapes, and competitive scenarios.

Key Points: 
  • Such factors drives the growth of the global passive temperature controlled packaging market.
  • According to the report, the passive temperature controlled packaging market size was valued at $10,286.1 million in 2021 and is projected to reach $24,462.0 million by 2031, registering a CAGR of 9.1% from 2022 to 2031.
  • Thus, the rise of the above-mentioned industries that extensively use passive temperature controlled packaging is anticipated to drive the growth of the passive temperature controlled packaging market during the forecast period.
  • The passive temperature controlled packaging market was severely hampered during the lockdown period owning to the outbreak of COVID-19.

Crystal Research Update Highlights 100% Responders Rate in Mild to Moderate COVID-19 Trial

Retrieved on: 
Wednesday, December 28, 2022
MOA, Investigational New Drug, OTCQB, COVID-19, Central Drugs Standard Control Organisation, Galectin, NMR, Patient, Preprint, FDA, Nuclear magnetic resonance, CDSCO, Crystal, IND, Lactose, Pharmaceutical industry

Crystal research reported that the Company announced positive topline safety and efficacy results from its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19.

Key Points: 
  • Crystal research reported that the Company announced positive topline safety and efficacy results from its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19.
  • The Company’s analysis also revealed an 88% response rate by day 3, which was statistically significant (p-value=.001).
  • The trial’s objective is to provide guidance for a 408 patient Phase III trial that will be finalized after analyzing the data from the optimization trial.
  • The update also covered the mechanism of action (MOA) detailed in the latest pre-print in greater depth.

Bioxytran Establishes Indian Subsidiary in Preparation of Commercialization

Retrieved on: 
Wednesday, December 14, 2022
CDSCO, Pulmonary fibrosis, FDA, Degenerative disease, Stroke, Galectin-3, Central Drugs Standard Control Organisation, OTCQB, Virology, Hypoxia, COVID-19, Pharmaceutical industry

BOSTON, MASSACHUSETTS, Dec. 14, 2022 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat COVID-19 and other viral causing diseases announced that it has established an Indian subsidiary (Pharmalectin India Private Limited).

Key Points: 
  • BOSTON, MASSACHUSETTS, Dec. 14, 2022 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat COVID-19 and other viral causing diseases announced that it has established an Indian subsidiary (Pharmalectin India Private Limited).
  • The purpose of the subsidiary is to launch commercial product sales of ProLectin-M should the company receive Central Drugs Standard Control Organization (CDSCO) approval.
  • The Indian manufacturing plant is an FDA approved facility capable of supporting the Indian market with a population of 1.4 billion people.
  • Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia.

Tianda Pharma Announces 2022/23 Interim Results

Retrieved on: 
Friday, November 25, 2022
Cloud, Marketing, COVID-19, D, BD, III, Prescription, Kerala State Drugs and Pharmaceuticals Limited, R, API, Policy, Patient, Heart, 3D, TCM, ID, Tsim Sha Tsui, Research, Central Drugs Standard Control Organisation, Depreciation, Traditional Chinese characters, CMO, Medicine, CDMO, Acquisition, Hong Kong Stock Exchange, Pharmaceutical industry, Fine chemical, Period

HONG KONG, Nov 25, 2022 - (ACN Newswire) - Tianda Pharmaceuticals Limited ("Tianda Pharma" or "the Group"; stock code: 0455.HK) today announced its interim results for the six months ended 30 September 2022 ("the Period").

Key Points: 
  • HONG KONG, Nov 25, 2022 - (ACN Newswire) - Tianda Pharmaceuticals Limited ("Tianda Pharma" or "the Group"; stock code: 0455.HK) today announced its interim results for the six months ended 30 September 2022 ("the Period").
  • During the Period, the Group adopted proactive marketing strategy and improved its results notably.
  • The Group has worked hard cultivating the cardiovascular, cerebrovascular and pediatric disease realms and owns unique generic product pipelines.
  • Boasting notable efficacy and competitive price, Tuoping Valsartan capsules, the Group's core product for treating cardio-cerebrovascular disease, has been ranked the No.