Torrent Pharma Derma Products

Examples: “SL-M2020W/XAA”. Include keywords along with product name. Tips for better search results. Ensure correct spelling and spacing - Examples:. Torrent Pharma, the flagship company of the Torrent Group, is one of the leading Pharma companies in India. Conceived as a small generic company in the early '70s by Late Shri U N Mehta, Torrent Pharma blazed a new trail in the Indian pharmaceuticals industry.

Torrent Pharmaceuticals Ltd. is the flagship company of the Torrent Group. Based in the Indian city of Ahmedabad. It was promoted by U. N. Mehta, initially as Trinity Laboratories Ltd, and was later renamed Torrent Pharmaceuticals Ltd.

Torrent Pharmaceuticals operates in more than 40 countries with over 2000 product registrations globally. Torrent Pharma is active in the therapeutic areas of Cardiovascular (CV), central nervous system (CNS), gastro-intestinal, diabetology, anti-infective and pain management segments. It has also forayed into the therapeutic segments of nephrology and oncology while also strengthening its focus on gynecology and pediatric segments.Drug firm Torrent Pharmaceuticals on 23 July 2019 reported a 32.51 percent rise in its consolidated net profit to Rs 216 crore for the quarter ended 30 June, mainly on account of robust sales in most geographies.^[1]

Subsidiaries[edit]

It has 7 fully owned subsidiaries:

1. Heumann Pharma GmbH & Co Generica KG, Germany
2. Torrent Pharma GmbH, Germany
3. Torrent do Brasil Ltda., Brazil
4. ZAO Torrent Pharma, Russia
5. Torrent Pharma Inc., United States
6. Torrent Pharma Philippines Inc., Philippines
7. Torrent Pharma Canada Inc., Canada
8. Torrent Pharma UK United Kingdom

Torrent Pharmaceuticals acquired Heumann GmbH, a Pfizer company, in 2005.

Operations[edit]

The company's key areas are Formulations, API, Drug Discovery, Marketing and Sales of Drugs. Its operations locations are:

• Manufacturing plant at Dahej, Gujarat
• Manufacturing plant^[2] at Pithampur^[3], Madhya Pradesh
• Manufacturing plant at Indrad, Mehsana, Gujarat
• Manufacturing plant at Baddi, Himachal Pradesh
• 3 Manufacturing plant at Rang-Po,(Sikkim)
• Research Centre, Ahmedabad-Gandhinagar region, Gujarat
• Corporate Office, beside sales India, off. Ashram Road, [Ahmedabad]- Gujarat
• Manufacturing plant at Visakhapatnam (Andhra Pradesh)

Recalls[edit]

In 2018, Torrent Pharmaceuticals recalled tablets containing valsartan^[4][5] and losartan^[6] due to the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) respectively which are probable human carcinogens.

In September 2019, the FDA issued notice of a sixth product recall of losartan by Torrent Pharmaceuticals when certain batches of losartan contained the contaminant, N-methylnitrosobutyric acid (NMBA), above acceptable daily intake levels determined by the FDA.^[7]

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References[edit]

1. ^'Torrent Pharma Q1 net profit up 33 percent to Rs 216 crore'. Medical Dialogues. 23 July 2019.
2. ^Sunkara, Keshav (19 January 2018). 'Torrent Pharma acquires US-based Bio-Pharm'. VCCIRCLE. Retrieved 20 July 2019.
3. ^PTI (18 March 2016). 'Torrent Pharma gets establishment nod from USFDA'. The Economic Times. Retrieved 20 July 2019.
4. ^'Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets'. 2018. Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
5. ^'FDA updates on valsartan recalls'. 2018.
6. ^'Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP'. 2018. Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
7. ^'Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP'. US Food and Drug Administration. 23 September 2019. Retrieved 23 September 2019.

Summary

Company Announcement

Torrent Pharmaceuticals Limitedis expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to theconsumerlevel due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers.Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

• 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

Consumers should also contact their physician or healthcareprovider if they have experienced any problems that may be related to taking or usingthis drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to Original Recall

Link to Updated Recall

Company Contact Information

Product Photos

• Regulated Product(s)