TO STUDY THE RECALLED DRUG RANITIDINE HYDROCHLORIDES IN DIFFERENT FORMULATIONS. Taj Pharmaceuticals by Taj Pharma

Taj Pharma with its Vendor SMS Life sciences are found to have NDMA / NDEA Free RANITIDINE API and Formulation as on 30/09/2019.

TO STUDY THE RECALLED DRUG RANITIDINE HYDROCHLORIDES IN DIFFERENT FORMULATIONS. 

Taj Pharmaceuticals Limited manufactures and distributes medicines.



The company’s products include prescription solutions, lifesaving drugs, anti-cancer drugs, veterinary products, consumer brands, and CNS drugs.



It focuses on medicines of anemia, anxiety disorders, cancer/oncology, ear infections, heart failure, hepatitis, HIV/AIDS, influenza, non-Hodgkin’s lymphoma, obesity, osteoporosis, Parkinson’s disease, pneumonia, transplantation, and common diseases.



Taj Pharmaceuticals Limited was founded in 2004 and its headquartered in Mumbai, India.

Prepared by: Rajuprasa Yadav M.S.Pharm (Biotechnology) Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Introduction Ranitidine Hydrochloride Tablet/Injection  Ranitidine Hydrochloride is first discovered in 1981.  Ranitidine is a H2 (histamine-2) blocker, which decreases the amount of acid secreted by the stomach and also relieve heartburn associated with acid ingestion and sour stomach.  Its approved for multiple indications, including treatment and prevention of ulcers of the stomach, intestines and also in treatment of gastroesophageal reflux disease.  The U.S. FDA has been found in 23/09/2019 and 25/09/2019 commonly known as the brand-name drug Zantac, and Apotex corp respectively which contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) as a human carcinogen.  NDMA is also known as environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Ranitidine HCL

Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Introduction:

 Taj Pharmaceuticals medicines.

Limited

manufactures

and

distributes

 The company’s products include prescription solutions, lifesaving drugs, anti-cancer drugs, veterinary products, consumer brands, and CNS drugs.

 It focuses on medicines of anemia, anxiety disorders, cancer/oncology, ear infections, heart failure, hepatitis, HIV/AIDS, influenza, non-Hodgkin’s lymphoma, obesity, osteoporosis, Parkinson’s disease, pneumonia, transplantation, and common diseases.  Taj Pharmaceuticals Limited was founded in 2004 and its headquartered in Mumbai, India.

RANITIDINE - Ranitidine Hydrochloride Tablet 150/300 mg Label.

Generic name: Ranitidine Hydrochloride Tablet USP 150 mg

Generic name: Ranitidine Hydrochloride Tablet USP 300 mg

Composition: Each tablet contains: Ranitidine hydrochloride USP Equivalent to Ranitidine 150 mg

Composition: Each tablet contains: Ranitidine hydrochloride USP Equivalent to Ranitidine 300 mg

Classification of the drugs Ranitidine is a commonly used drug, classified as a histamine H2-receptor antagonist. Sr.No.

Brand Name

Dosage Form:

Generic name

Strength

Purpose

Uses

Axid AR

tablet, film coated

Nizatidine

75 mg

Acid reducer

Relieves heartburn Acid indigestion Sour stomach

Pepcid AC

Injection Tablet, film coated, oral suspension powder and suspension liquid

Famotidine

20 mg

Acid reducer

Treat and prevent ulcers in the stomach and intestines.

Tagamet

Oral Tablet, Oral Liquid, IV, IM Solution, Compounding Powder

Cimetidine

Tab: 200/300/400/800mg ORS: Dilute 300 mg in 20/50ml with 0.9% NaCl Inj For IV: 150 mg of Cimetidine

Acid reducer

Treat Duodenal ulcer Gastroesophageal Reflux (GERD) Upper GI Bleeding

Zantac

Injection Syrups , tablets, Capsiules

Ranitidine

25mg/ml 15mg/ml Tab:75/150/300 mg Cap: 150mg/300mg

Acid reducer

Relieves heartburn associated with acid indigestion and sour stomach

Berkley and Jensen Acid Controller Complete

Complete Dosage forms

famotidine, calcium carbonate and magnesium hydroxide

Famotidine; 10 mg CaCO3 :800 mg Mg(OH)2 :165 mg

Acid reducer

Relieves heartburn associated with acid indigestion and sour stomach

Deprizine

Kit for oral suspension

Ranitidine hydrochloride

4.2 g ranitidine HCL, USP

Acid reducer

Antacid

Relieves heartburn associated with acid indigestion and sour stomach

Chemical synthesis of Ranitidine

http://drugsynthesis.blogspot.com/2012/05/laboratory-synthesis-ofranitidine.html Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Mechanism of action  Ranitidine is a Histamine2-receptor antagonist (H2-blocker) that blocks histamine-induced gastric acid secretion.  It suppresses histamine stimulation of gastric parietal cells to decrease gastric acid secretion due to their prokinetic activity through inhibiting Acetylcholinesterase (ACHE).  While in case of cimetidine and famotidine are not Acetylcholinesterase (ACHE) inhibitors and do not have prokinetic effect.  Ranitidine will increase stomach pH. https://www.sciencedirect.com/topics/pharmacology-toxicology-andpharmaceutical-science/ranitidine

INDICATIONS AND USAGE  Most patients heal within 4 weeks in short-term treatment

of active duodenal ulcer.  Maintenance therapy applied for duodenal ulcer patients

at reduced dosage after healing of acute ulcers.  It helps in treatment of pathological hypersecretory

conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).  Most patients heal within 6 weeks in the short-term

treatment of active, benign gastric ulcer  Maintenance therapy for gastric ulcer patients at reduced

dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

Continued….  Treatment of GERD. Symptomatic relief commonly occurs

within 24 hours after starting therapy with ranitidine 150 mg twice daily.  Treatment of endoscopically diagnosed erosive esophagitis.

Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.  Maintenance of healing of erosive esophagitis. Placebo-

controlled trials have been carried out for 48 weeks.  Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hyper secretory states; GERD; and erosive esophagitis. Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

CONTRAINDICATIONS  If you are in allergies with or without any other H2

Blockers (cimetidine, famotidine, nizatidine).

 Certain blood disorders (Prophyria), Heart problems

(irregular heart beat), Lungs problems (Ashthama,Chronic COPD) and other stomach problems like tumours.  Its passes into breast milk so consult your doctor before

breast feeding.  But now its recalled for some pharmaceutical company

(Novartis- Zantac and Sandoz)due to major impurity like N-nitrosodimethylamine (NDMA) which cause human carcinogenic effect. https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity

Side effects  Headache, constipation, or diarrhea may occur.  Pain, redness, burning, or stinging may occur at the injection

site.  It also cause sometimes blurred vision, mental mood changes

(nervousness, confusion, depression hallucinations), enlarged breast.  Irregular heartbeat, stomach pain, dark urine, yellowing

eyes/skin  A very serious Allergic reaction to this drug is rare, dizziness,

trouble breathing etc. Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

CLINICAL PHARMACOLOGY Pharmacokinetics Study

Absorption:  50% absorbed  Absorption is not significantly impaired by the administration of food or antacids

Distribution:  The volume of distribution is about 1.4 L/kg.  Serum protein binding average 15%

Metabolism:  N-oxide major metabolite in urine <4%  S-oxide (1%)  Desmethyl Ranitidine (1%)  Remains of the Dose found in stool.

Excretion:  Mainly urine30%  Renal Clearance 410ml/minut e  Elimination t1/2 -2.5 to 3 hrs.

Continued Pharmacodynamics Study ď&#x201A;§ Serum concentrations necessary to inhibit 50% of stimulated gastric acid secretion are estimated to be 36 to 94 ng/ml. ď&#x201A;§ Single oral dose of 150/300mg, Serum concentration of ranitidine up to 12 hours. ď&#x201A;§ Ant secretory Activity: a) Effects on Acid Secretion: I. Ranitidine inhibits both daytime and nocturnal basal gastric acid secretions as well as gastric acid secretion stimulated by food, betazole, and pentagastrin. II. It appears that basal-, nocturnal-, and betazole-stimulated secretions are most sensitive to inhibition by ranitidine, responding almost completely to doses of 100 mg or less, while pentagastrin- and food-stimulated secretions are more difficult to suppress. b) . Effects on Other Gastrointestinal Secretions: Pepsin: oral ranitidine doesn't affect, Even total pepsin output is reduced as decrease in volume of gastric juice. Intrinsic factor: No significant effect on pentagastrin-stimulated intrinsic factor secretion. Serum gastrin: No effect on fasting or postprandial serum gastrin. Taj Pharmaceuticals Ltd India | Taj Pharma | Taj Pharmaceuticals Mumbai, Company Overview of Taj Pharmaceuticals Limited |Taj Pharmaceuticals Limited Taj Pharmaceutical an Industrial conglomerate, having diversified interest in Pharmaceuticals and healthcare, Chemicals, API and Agro commodities mainly offers unique opportunities for all its associates to grow in capacity as one of a significant part in curing lives worldwide and building a disease-free nation. Taj Pharma is having more than 600+ brands in different divisions and multiple subsidiaries to meet up most of the requirements of buyers in our industry along with a very efficient staff management capacity.

FDA recalled to ranitidine hydrochlorides (Apotex Corp.) Sr. No. 1 2

3 4

5 6

Product name

Strength

Pack Size

NDC number

Ranitidine tablets, USP 150mgacid reducer (Rite Aid) Ranitidine tablets, USP 150mgacid reducer (Rite Aid) Ranitidine tablets, USP 150mgacid reducer (Rite Aid) Ranitidine tablets, USP 150mgacid reducer (Walmart) Ranitidine tablets, USP 150mgacid reducer (Walmart) Wal-ZanÂŽ 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)

150 mg

50's Bottle

11822-6052-1

150 mg

65's Bottle

11822-6052-2

150 mg

95's Bottle

11822-4727-3

150 mg

65's Bottle

49035-117-06

150 mg

24's Bottle

49035-100-00

150 mg 200's Bottle

0363-1030-07

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corpissues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes

Continue…. Product Sr. No. 1 Ranitidine tablets, USP 150 mg acid reducer (Rite Aid) 2 Ranitidine tablets, USP 150mgacid reducer (Walmart) 3 Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) 4 Wal-Zan® 75 RANITIDINE TABLETS, USP 75 mg / ACID REDUCER (WALGREENS) 5 Cool mint Ranitidine tablets, USP 150 mg - acid reducer (Rite Aid) 6 Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS) 7 Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)

Strength 150 mg

Pack Size NDC Number 24's Bottle 11822-6051-8

150 mg

130's Bottle 49035-100-07

150 mg

24's Bottle

0363-1013-02

75 mg

30's Bottle

0363-1029-03

150 mg

24's Bottle

11822-6107-4

150 mg

65's Bottle

0363-1030-06

150 mg

95's Bottle

0363-1030-09

FDA recalled to ranitidine hydrochlorides (Sandoz Inc.)

Product Name RANITIDINE 150mg Capsules 500 count RANITIDINE 150mg Capsules 500 count RANITIDINE 150mg Capsules 500 count RANITIDINE 150mg Capsules 500 count RANITIDINE 150mg Capsules 60 count RANITIDINE 150mg Capsules 60 count RANITIDINE 150mg Capsules 60 count RANITIDINE 150mg Capsules 60 count

NDC Number

Exp. Date

Mfg. Date of

0781-2855-05 HD1862

4/30/2020

4/19/2017

0781-2855-05 HP9438

9/30/2020

9/5/2017

0781-2855-05 HP9439

9/30/2020

9/6/2017

0781-2855-05 HP9440

9/30/2020

9/5/2017

0781-2855-60 HC9266

4/30/2020

4/19/2017

0781-2855-60 HD1865

4/30/2020

4/19/2017

0781-2855-60 HP9441

9/30/2020

9/6/2017

0781-2855-60 JK7994

8/31/2021

8/7/2018

Lot No.

Continueâ&#x20AC;¦.. Product Name

NDC No.

Lot No.

Exp. Date

Mfg. Date

RANITIDINE 150mg Capsules 60 count

0781-2855-60

JK8659

8/31/2021

8/7/2018