Ranitidine Study by Taj Pharma

Prepared by:
Rajuprasa Yadav
M.S.Pharm (Biotechnology)
TO STUDY THE RECALLED DRUG RANITIDINE
HYDROCHLORIDES IN DIFFERENT FORMULATIONS.
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.
 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.
Taj Pharma with its Vendor SMS Life
sciences are found to have NDMA / NDEA
Free RANITIDINE API and Formulation as
on 30/09/2019.

Introduction
Ranitidine HCL
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
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 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.

RANITIDINE - Ranitidine Hydrochloride Tablet 150/300 mg Label.
Composition:
Each tablet contains:
Ranitidine hydrochloride USP
Equivalent to Ranitidine 150 mg
Generic name:
Ranitidine Hydrochloride Tablet USP 150 mg
Composition:
Each tablet contains:
Ranitidine hydrochloride USP
Equivalent to Ranitidine 300 mg
Generic name:
Ranitidine Hydrochloride Tablet USP 300 mg

Classification of the drugs
Sr.No. Brand Name Dosage Form: Generic name Strength Purpose Uses
1 Axid AR tablet, film coated Nizatidine 75 mg Acid reducer Relieves heartburn
Acid indigestion
Sour stomach
2 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.
3 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
4 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
5 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
Antacid
Relieves heartburn associated
with acid indigestion and sour
stomach
6 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
Ranitidine is a commonly used drug, classified as a histamine
H2-receptor antagonist.

Chemical synthesis of Ranitidine
http://drugsynthesis.blogspot.com/2012/05/laboratory-synthesis-of-
ranitidine.html

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-and-
pharmaceutical-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.

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.

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.

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 urine-
30%
 Renal
Clearance
410ml/minut
e
 Elimination
t1/2 -2.5 to 3
hrs.

Continued Pharmacodynamics Study
 Serum concentrations necessary to inhibit 50% of stimulated gastric acid secretion
are estimated to be 36 to 94 ng/ml.
 Single oral dose of 150/300mg, Serum concentration of ranitidine up to 12 hours.
 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.

Sr.
No.
Product name Strength Pack Size NDC number
1 Ranitidine tablets, USP 150mg-
acid reducer (Rite Aid)
150 mg 50's Bottle 11822-6052-1
150 mg 65's Bottle 11822-6052-2
150 mg 95's Bottle 11822-4727-3
acid reducer (Walmart)
150 mg 65's Bottle 49035-117-06
150 mg 24's Bottle 49035-100-00
6 Wal-Zan® 150 RANITIDINE
TABLETS, USP 150 mg / ACID
REDUCER (WALGREENS)
150 mg 200's Bottle 0363-1030-07
FDA recalled to ranitidine hydrochlorides (Apotex
Corp.)
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-
issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes

Sr. No. Product Strength Pack Size NDC Number
1 Ranitidine tablets, USP 150 mg -
150 mg 24's Bottle 11822-6051-8
150 mg 130's Bottle 49035-100-07
REDUCER (WALGREENS)
150 mg 24's Bottle 0363-1013-02
REDUCER (WALGREENS)
75 mg 30's Bottle 0363-1029-03
5 Cool mint Ranitidine tablets, USP
150 mg - acid reducer (Rite Aid)
150 mg 24's Bottle 11822-6107-4
REDUCER (WALGREENS)
150 mg 65's Bottle 0363-1030-06
REDUCER (WALGREENS)
150 mg 95's Bottle 0363-1030-09
Continue….

Product Name
NDC
Number Lot No.
Exp.
Date
Mfg.
Date of
RANITIDINE 150mg
Capsules 500 count
0781-2855-05 HD1862 4/30/2020 4/19/2017
RANITIDINE 150mg
Capsules 500 count
0781-2855-05 HP9438 9/30/2020 9/5/2017
RANITIDINE 150mg
Capsules 500 count
0781-2855-05 HP9439 9/30/2020 9/6/2017
RANITIDINE 150mg
Capsules 500 count
0781-2855-05 HP9440 9/30/2020 9/5/2017
RANITIDINE 150mg
Capsules 60 count
0781-2855-60 HC9266 4/30/2020 4/19/2017
RANITIDINE 150mg
Capsules 60 count
0781-2855-60 HD1865 4/30/2020 4/19/2017
RANITIDINE 150mg
Capsules 60 count
0781-2855-60 HP9441 9/30/2020 9/6/2017
RANITIDINE 150mg
Capsules 60 count
0781-2855-60 JK7994 8/31/2021 8/7/2018
FDA recalled to ranitidine hydrochlorides (Sandoz Inc.)

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
30 count
0781-2865-31 HD8625 4/30/2020 4/27/2017
30 count
0781-2865-31 HD9275 4/30/2020 4/27/2017
30 count
0781-2865-31 HU2207 8/31/2020 8/24/2017
30 count
0781-2865-31 HX6676 3/31/2021 3/20/2018
30 count
0781-2865-31 HX6677 3/31/2021 3/20/2018
Continue…..
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-
recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated

Ranitidine recalled products view

What is NDMA
 N-nitrosodimethylamine (NDMA) is a known environmental
contaminant and found in water and foods, including meats,
dairy products, and vegetables.
 It is probable human carcinogenic (that could cause cancer).
 U.S. FDA has been recalled some companies ranitidine
hydrochlorides drug products like Apotex Corp and Sandoz
Inc.
 FDA has been observed that the testing methods for NDMA
is not suitable at higher temperature because of higher
temperature generates NDMA on products.
 Finally FDA has recommended an LC-HRMS testing
protocol to test sample Ranitidine (Not in elevated temp.)
and has shown much lower levels of NDMA in ranitidine.
 FDA will test ranitidine oral solution and has begun testing
sample of other H2 blockers and proton pump inhibitors.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-
announcements-ndma-zantac-ranitidine

FDA alerts health care professionals and patients
 Not all ranitidine medicines marketed in the U.S. are being
recalled.
 FDA is not recommending individuals stop taking all
ranitidine medicines at this time.
 Consumers taking OTC ranitidine could consider using other
OTC products approved for their condition.
 Patients taking prescription ranitidine who wish to
discontinue use should talk to their health care professional
about other treatment options. Multiple drugs are approved
for the same or similar uses as ranitidine.
What patients should know

 Multiple drugs are approved for the same or
similar uses as ranitidine.
 Health care professionals should discuss other
treatment options with patients who are concerned
about ranitidine.
 If you have samples of recalled ranitidine, do not
provide them to patients.
What health care professionals should know

Role of Taj pharmaceuticals as Generic manufacture
 Taj pharmaceuticals is continuing to test and generte new
protocol to control the NDMA impurity on their own ranitidine
products as well as others.

 It recommends to manufacturer to reduce the temperature at
working area because of NDMA is comes on products at elevated
temperature.
 It recommends to pharma industry as well as health care
professional to keep API and finished product also below the
room temperature.
 It recommends health care professional to take alternative
medicine which is on same same target like famotidine is a
potent drug under the supervision of the respective Doctors and
Pharmacist.

Conclusion & Recent outcomes Study
 Due to overall study of the recalled ranitidine products
people should not take ranitidine as its available in
OTC.
 NDMA is highly human carcinogen so healthcare
professionals should aware to people about this
recalled products.
 The pharmaceutical manufactures should withdraw
their recalled products from the market.
 Taj Pharma with its Vendor SMS Life sciences are
found to have NDMA / NDEA Free RANITIDINE
API and Formulation as on 30/09/2019.

Ranitidine Study by Taj Pharma

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Ranitidine Study by Taj Pharma

Similar to Ranitidine Study by Taj Pharma (20)

More from Shantanu Kumar Singh

More from Shantanu Kumar Singh (20)

Recently uploaded

Recently uploaded (20)

Ranitidine Study by Taj Pharma