Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
3. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (20mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP……….20mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine……………5mg
Hydrochlorothiazide USP…………….12.5mg
Excipients……………………………………q.s
Color: Sunset yellow FCF

2. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 5mg+12.5mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP…………40mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine………………5mg
Hydrochlorothiazide USP………………12.5mg
Excipients………………………………………q.s
Color: Brilliant blue FCF

3. Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+ 10mg+25mg)
Each film-coated tablet contains:
Olmesartan Medoxomil USP…………40mg
Amlodipine Besilate USP               6.94mg
Equivalent to Amlodipine………………10mg
Hydrochlorothiazide USP……………….25mg
Excipients………………………………………q.s
Color: Orange G

THERAPEUTIC INDICATIONS:

Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight container with a child-resistant closure.
It is dangerous to take this preparation except under Medical supervision.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

When pregnancy is detected, Olmesartan should be discontinued as soon as possible, as it can cause injury and even death to the developing fetus, when used during the second and third trimester of pregnancy.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) ; excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction: What Is Olmesartan + Amlodipine + Hydrochlorothiazide (40 mg + 10 mg + 25 mg)?

High blood pressure (hypertension) remains a top global health challenge, responsible for a significant share of strokes, heart attacks, and heart failure. In many patients, a single drug is insufficient to achieve target pressure; hence, triple-combination therapies have become highly demanded in cardiovascular therapeutics.

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg) combine three complementary mechanisms:

• Olmesartan Medoxomil (40 mg) is an angiotensin receptor blocker (ARB). It blocks angiotensin II from binding to AT₁ receptors, thereby relaxing blood vessels and reducing vasoconstriction.

• Amlodipine (10 mg) is a calcium channel blocker (CCB). It reduces calcium influx into vascular smooth muscle, causing arterial dilation.

• Hydrochlorothiazide (25 mg) is a thiazide diuretic. It increases urinary excretion of sodium and water, lowering circulating volume and blood pressure. Over time, it also exerts some vascular relaxation effect.

This triple combination is typically prescribed when monotherapy or dual therapy fails to control hypertension effectively. The synergy helps reduce systolic and diastolic pressure more robustly than individual components alone, and can lower the risk of cardiovascular events like stroke or myocardial infarction.

Globally, demand for fixed-dose combination antihypertensives is rising because they improve patient adherence (fewer pills), simplify regimens, and reduce costs. Developing nations, in particular, represent key markets. Hence, international buyers (importers, distributors, government tenders) seek reliable Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg) manufacturer in India.

2. Exporter/Importer Essentials: What International Buyers Look For

When procuring Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg) from India or elsewhere, importers demand not only quality but a full suite of regulatory support, documentation, packaging flexibility, and shelf stability. Below is what discerning buyers expect:

Regulatory Documentation & Certifications

1. Certificate of Pharmaceutical Product (COPP / CPP)
   Many importing regulatory authorities require COPP issued in WHO format to ascertain the product status in the exporting country (i.e. legal marketing status, GMP compliance).

2. WHO-GMP / cGMP / EU-GMP / PIC/S GMP certification
   To supply to regulated markets, the manufacturer must hold GMP certifications recognized internationally. Taj Pharma’s facilities are audited to WHO-GMP, ISO, and related standards.

3. CTD / Dossier (Module 1–5)
   A complete Common Technical Document (CTD) dossier allows registration filing in target markets (pharmacology, stability, manufacturing, quality control).

4. Analytical method validations, stability data, impurity profiles
   Detailed reports showing validated methods, forced degradation studies, and long-term stability are mandatory for regulatory review.

5. Regulatory support letters, free sale certificate
   A “Free Sale Certificate” confirming that the product is allowed for sale in India supports import registration.

6. Export license, drug license, IEC code
   The manufacturer must have valid Indian export drug licenses, import-export code and drug manufacturing licenses. artemusgroupusa.com+1

Custom Packaging & Labeling Flexibility

Importers often require:

• Local language labeling

• Batch numbering format per local regulations

• Custom packaging sizes (blister packs, bottles, boxes)

• Tamper-evident seals, serialization

• Childproof or unit dose options

A reliable manufacturer allows these customizations without delays.

Shelf Life, Storage & Dosage Form

• Typical shelf life for finished tablets is 24–36 months under ICH stability protocols.

• Recommended storage: “Store in a cool, dry place, protected from moisture and heat” (e.g. 25 °C, RH ≤60 %).

• Tablet form: film-coated, scored or non-scored, standard 9 mm / 12 mm size.

• Standard excipients (stability enhancers, coatings) used to maintain drug integrity over shelf life.

Export Markets & Target Countries

Key export destinations for antihypertensive combinations include:

• Latin America (e.g., Brazil, Mexico, Argentina)

• Africa (Nigeria, Kenya, South Africa)

• Southeast Asia (Philippines, Indonesia, Vietnam)

• Middle East & Central Asia

• Eastern Europe, CIS countries

Exporters often maintain registrations or partners in 10–20 countries, supplying via tenders, private markets, or government programs.

3. Why Taj Pharma Is the Most Trusted Manufacturer / Supplier / Exporter

Taj Pharma (Taj Pharmaceuticals / Taj Pharma Group) is widely recognized among India’s top generics companies. Let’s explore why global buyers trust Taj Pharma as the Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg) Manufacturer in India.

State-of-the-Art Manufacturing & Quality Control

• Taj Pharma has modern finished dosage manufacturing facilities in Gujarat (Sarigam / Valsad region) that cater to tablets, capsules, injectables, etc. Taj Pharma  

• The facilities operate under WHO-cGMP, GLP, ISO 9001:2018 standards. tajpharmaindia.com

• Dedicated clean rooms, analytical labs, microbiology labs ensure product safety, uniformity, and batch reproducibility. tajpharmaindia.com

• Taj Pharma’s quality assurance system includes raw-material screening, in-process checks, finished product testing, stability monitoring, and batch release protocols.

Affordable Pricing with Quality Assurance

• India—especially Gujarat—is a cost-competitive hub for pharmaceutical manufacturing.

• Taj Pharma strikes a balance by offering globally acceptable formulations at prices affordable to importers, without compromising on quality.

• Their economies of scale (multiple product lines, large volumes) help reduce costs further for clients.

Regulatory Compliance & Global Reach

• Taj Pharma’s export orientation means they maintain all required certifications and support documentation.

• The company is registered to serve global generics demand across many markets. Taj Pharma India+1

• Their past audits by international regulators (regulatory inspections) ensure that they are prepared for regulatory scrutiny. Taj Pharma India+1

• Taj Pharma’s global generics strategy focuses on therapeutic areas including cardiovascular and CNS (central nervous system) segments. Taj Pharma Group+1

Global Supply Chain & Support

• Taj Pharma supports logistics, warehousing, and consignment shipments internationally.

• They manage documentation (COA, GMP certificates, export licenses) and can interface with freight forwarders or shipping agents.

• Their reach into multiple geographies ensures resilience in supply chains and consistent delivery.

Market Presence & Export Footprint

While Taj does not publicly list a fixed “Top 20 countries” for all products, as a leading pharma exporter, they already supply to multiple regulated and semi-regulated markets globally. Given their generic product portfolio exceeding 4,600 compositions  their reach is wide.

Hence, Taj Pharma is arguably among the top picks for importers seeking Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg) with trust, compliance, and scale.

4. Technical Product Specification Table

Below is a sample technical specification table for Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg) as typically supplied by a manufacturer like Taj Pharma:

Importers can request modifications to e.g. coating type, scoring, packaging format, or shelf life as per local regulations.

5. Call to Action:

If you are an international buyer, distributor, government health agency, or pharma franchise partner seeking a reliable, compliant, and cost-effective source of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg), Taj Pharma is your ideal partner.

Contact them today to:

• Request a quotation (FOB / CIF / DAP) for your required volume

• Get the CTD dossier, COA, GMP certificate, and sample

• Define custom packaging, labeling, registration support

• Strengthen your supply chain with a trusted, global manufacturer

Contact Details
Taj Pharma India — headquarters Mumbai, manufacturing in Gujarat.  
Email: info@tajpharma.com (queries forwarded to respective departments)  
Toll-free helpline (India): 1800 222 434 / 1800 222 825

Start a conversation now to secure high-quality Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40mg+10mg+25mg) that your customers and regulators will trust.

6. Top 20 FAQs

1.  Q: What is Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg)?
   A: It is a fixed-dose triple combination drug used to treat hypertension (high blood pressure) when single or dual therapy is insufficient.

2. Q: How do these three drugs work together?
   A: Olmesartan blocks angiotensin II receptors, Amlodipine relaxes vascular smooth muscle, and Hydrochlorothiazide promotes diuresis (urine excretion) — together they lower pressure synergistically.

3. Q: What are common side effects?
   A: Headache, dizziness, nausea, upper respiratory infection, fatigue, urinary tract infection, diarrhea, joint swelling, peripheral edema, nasopharyngitis, muscle spasm. Use cautiously.

4. Q: Is it prescription-only?
   A: Yes — this is a prescription-only medication in virtually all jurisdictions due to potential risks and need for monitoring.

5. Q: Can it cause dizziness or dehydration?
   A: Yes. Risk of dizziness is there; patients should rise slowly from sitting/lying. It may also cause dehydration; patients are advised to drink adequate fluids and monitor for extreme thirst, muscle weakness, or dry mouth.

6. Q: What should patients monitor?
   A: Blood pressure, electrolytes (especially sodium, potassium), kidney function (creatinine), signs of dehydration, edema, or other side effects.

7. Q: What is the typical shelf life?
   A: Usually 24–36 months under ICH stability conditions (e.g., 25 °C / RH 60 %).

8. Q: What storage conditions are needed?
   A: Store in a cool, dry place, away from moisture, heat, and direct sunlight. Usually <25–30 °C.

9. Q: What packaging formats are available?
   A: Blister packs (Alu-Alu or Alu-PVC), HDPE bottles, cartons, with foil wraps. Custom packaging per buyer is possible.

10. Q: Can buyers request custom labeling / languages?
    A: Yes — manufacturers like Taj Pharma typically offer customized labeling, local languages, batch coding, and serialization.

11. Q: What export certifications come with each batch?
    A: COA, GMP compliance certificate, Free Sale Certificate, stability summary, validated methods, and other regulatory support docs.

12. Q: What dossier format is supplied?
    A: A full CTD dossier (Modules 1–5) or local dossier format as required by the importing country.

13. Q: What impurities are controlled?
    A: Pharmacopoeial limits for individual and total unknown impurities, as well as known degradants per pharmacopeia or regulatory norms.

14. Q: Can the manufacturer assist in local registration?
    A: Yes — many exporters provide technical support, data transfer, and liaison with regulatory agencies.

15. Q: Is the manufacturer GMP certified?
    A: Yes — for example, Taj Pharma is audited for WHO-cGMP, ISO 9001 standards.

16. Q: Can I get sample before bulk purchase?
    A: Yes — most reputable manufacturers supply registration / commercialization samples under NDA for evaluation.

17. Q: What is minimum order quantity (MOQ)?
    A: It depends on manufacturer policy — typical MOQs range from tens of thousands to hundreds of thousands of tablets, depending on packaging and export logistics.

18. Q: What are the payment terms?
    A: Common terms include L/C (Letter of Credit), TT (Telegraphic Transfer), D/P, CAD etc., negotiable based on client relationship.

19. Q: What are lead times?
    A: After order confirmation and regulatory checks, lead times usually span 4–8 weeks, depending on packaging, registration, and shipping arrangements.

20. Q: How safe is this triple combination?
    A: When prescribed and monitored appropriately, it is considered safe and effective. However, risks include hypotension, electrolyte imbalance, renal function changes, and drug interactions. Medical supervision is essential.

In summary, Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets (40 mg + 10 mg + 25 mg) represent a high-demand fixed-dose combination in modern hypertension management. For global buyers seeking supply, Taj Pharma stands out as a credible, quality-driven, export-compliant manufacturer, supplier, and exporter from India, particularly in the Gujarat / Vapi region.