WHO-GMP Third-Party Manufacturer in India

Strategic Pharmaceutical Partnership for Global Expansion Through WHO-GMP Manufacturing Excellence

The pharmaceutical industry continues to evolve rapidly, creating unprecedented opportunities for companies seeking expansion into emerging and high-growth markets. Across Asia and Africa, healthcare demand is increasing at a remarkable pace, driven by population growth, improved healthcare infrastructure, government initiatives, and rising awareness of quality medicines. In this dynamic environment, successful market expansion requires more than just a product portfolio—it demands a reliable manufacturing partner with proven regulatory expertise, scalable production capabilities, and comprehensive export support.

As a leading pharmaceutical manufacturer operating from a WHO-GMP, GLP, and RCMC certified facility, we offer strategic partnerships designed to help pharmaceutical companies accelerate their growth across international markets. Through our specialized capabilities in Third-Party Manufacturing and Merchant Export Services, we provide a complete platform for organizations seeking sustainable expansion and long-term competitive advantage.

---

Why Strategic Pharmaceutical Partnerships Are Essential for Global Growth

Global pharmaceutical markets have become increasingly competitive. Companies aiming to establish or strengthen their presence in Africa, Asia, the Middle East, Latin America, and CIS countries face numerous challenges, including:

• Regulatory compliance requirements
• Product registration complexities
• Supply chain management
• Product sourcing challenges
• Market-specific documentation requirements
• Quality assurance expectations
• Competitive pricing pressures

A strategic partnership with an experienced pharmaceutical manufacturer eliminates many of these obstacles. By leveraging established infrastructure, regulatory resources, and manufacturing expertise, companies can significantly reduce market entry timelines and optimize operational efficiency.

Our commitment is to provide a comprehensive partnership model that supports every stage of international business development.

---

WHO-GMP, GLP, and RCMC Certified Manufacturing Excellence

Quality remains the foundation of pharmaceutical success. Our manufacturing facility located in the Sarigam Industrial Zone, Vapi-Daman Region, India, operates under stringent international quality standards.

Our certifications include:

• WHO-GMP Certification
• GLP Compliance
• RCMC Registration
• International quality management systems
• Robust quality assurance protocols
• Advanced production infrastructure

These certifications demonstrate our commitment to maintaining consistent product quality, regulatory compliance, and manufacturing excellence across all production activities.

Every formulation is developed and manufactured using validated processes, ensuring compliance with international regulatory requirements and customer expectations.

---

REGULATORY STATUS & DOSSIER AVAILABILITY

Product Name	Strength	Pharmacopoeial Standard	Pharmaceutical Form	Available Dossiers
Azithromycin	500 mg	BP	Tablet	CTD + ACTD
Azithromycin	250 mg	BP	Tablet	CTD + ACTD
Itraconazole	200 mg	BP	Capsule	CTD + ACTD
Sildenafil Citrate	100 mg	BP	Tablet	CTD + ACTD
Tramadol Hydrochloride	100 mg	USP	Tablet	CTD
Sildenafil Citrate	50 mg	USP	Tablet	CTD
Tadalafil	20 mg	BP	Tablet	CTD
Tadalafil	10 mg	USP	Tablet	CTD
Levocetirizine Dihydrochloride	5 mg	USP	Tablet	CTD
Levocetirizine Dihydrochloride + Montelukast	5 mg + 10 mg	USP / BP	Tablet	CTD
Albendazole	400 mg	USP	Tablet	CTD
Rosuvastatin	20 mg	BP	Tablet	CTD
Paracetamol + Acetylsalicylic Acid + Caffeine	500 mg + 250 mg + 65 mg	USP / BP / BP	Tablet	CTD
Paracetamol	500 mg	BP	Tablet	CTD
Paracetamol + Propyphenazone + Caffeine	250 mg + 150 mg + 50 mg	USP / BP / BP	Tablet	CTD
Tramadol Hydrochloride	50 mg	USP	Tablet	CTD
Flupirtine Maleate	100 mg	In-house	Capsule	CTD
Propranolol Hydrochloride	20 mg	BP	Tablet	CTD
Thiamine Hydrochloride	100 mg	USP	Tablet	CTD

TAJ PHARMA – PRODUCTS LIST (TABLETS / CAPSULES / CREAMS)

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class (Estimate)
Azithromycin	Azitaj	Macrolide Antibiotic	Tablet	250 mg, 500 mg	Class III
Itraconazole	Itrataj	Antifungal	Capsule	200 mg	Class II
Sildenafil Citrate	Sildataj	Erectile Dysfunction Therapy	Tablet	50 mg, 100 mg	Class II
Tramadol Hydrochloride	Tramataj	Analgesic / Pain Management	Tablet	50 mg, 100 mg	Class I
Tadalafil	Tadataj	Erectile Dysfunction Therapy	Tablet	10 mg, 20 mg	Class II
Levocetirizine Dihydrochloride	Levotaj	Antihistamine / Anti-Allergic	Tablet	5 mg	Class III
Levocetirizine Dihydrochloride + Montelukast Sodium	Levomont-Taj	Anti-Allergic / Anti-Asthmatic	Tablet	5 mg + 10 mg	Class III
Albendazole	Albetaj	Anthelmintic	Tablet	400 mg	Class II
Rosuvastatin Calcium	Rosutaj	Antihyperlipidemic	Tablet	20 mg	Class II
Paracetamol + Acetylsalicylic Acid + Caffeine	Analgetaj Plus	Analgesic / Antipyretic	Tablet	500 mg + 250 mg + 65 mg	N/A
Paracetamol	Parataj	Analgesic / Antipyretic	Tablet	500 mg	Class I
Paracetamol + Propyphenazone + Caffeine	Analgetaj Forte	Analgesic / Pain Relief	Tablet	250 mg + 150 mg + 50 mg	N/A
Flupirtine Maleate	Flupitaj	Non-Opioid Analgesic	Capsule	100 mg	Class II
Propranolol Hydrochloride	Proprataj	Beta Blocker / Antihypertensive	Tablet	20 mg	Class I
Thiamine Hydrochloride (Vitamin B1)	Thiamtaj	Vitamin Supplement	Tablet	100 mg	Class III

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class (Estimate)
Aminophylline	Aminotaj	Bronchodilator / Anti-Asthmatic	Tablet	100 mg	Class III
Amitriptyline Hydrochloride	Amitaj	Antidepressant	Tablet	25 mg	Class I
Amoxicillin	Amoxtaj	Antibiotic (Penicillin)	Dispersible Tablet	250 mg, 500 mg	Class I
Artemether + Lumefantrine	Artemtaj-L	Antimalarial	Tablet	20 mg + 120 mg	Class IV
Atenolol	Atenotaj	Antihypertensive (Beta Blocker)	Tablet	50 mg, 100 mg	Class III
Carbamazepine	Carbataj	Antiepileptic	Tablet	200 mg	Class II
Chloroquine Base	Chlorotaj	Antimalarial	Tablet	150 mg	Class I
Cloxacillin	Cloxtaj	Antibiotic (Penicillin)	Capsule	250 mg, 500 mg	Class III
Diazepam	Diaztaj	Anxiolytic / Sedative	Tablet	5 mg	Class I
Digoxin	Digitaj	Cardiac Glycoside	Tablet	250 mcg	Class I
Doxycycline	Doxytaj	Antibiotic (Tetracycline)	Tablet	100 mg	Class I
Ferrous Sulfate	Ferrotaj	Hematinic	Tablet	60 mg	Class III
Fluoxetine	Fluotaj	Antidepressant (SSRI)	Capsule	20 mg	Class I
Furosemide	Furotaj	Diuretic	Tablet	40 mg	Class IV
Glibenclamide	Glibetaj	Antidiabetic	Tablet	5 mg	Class II
Haloperidol	Halotaj	Antipsychotic	Tablet	5 mg	Class I
Hydrochlorothiazide	Hydrotaj	Diuretic / Antihypertensive	Tablet	25 mg	Class IV
Isosorbide Dinitrate	Isotaj	Antianginal	Sublingual Tablet	5 mg	Class I
Mebendazole	Mebetaj	Anthelmintic	Chewable Tablet	100 mg	Class IV
Metformin Hydrochloride	Mettaj	Antidiabetic	Tablet	500 mg	Class III
Methyldopa	Methytaj	Antihypertensive	Tablet	250 mg	Class III
Metronidazole	Metrotaj	Antiprotozoal / Antibacterial	Tablet	250 mg, 500 mg	Class I
Misoprostol	Misotaj	Obstetrics & Gynecology	Tablet	200 mcg	Class I
Multi-Micronutrients	Nutritaj	Nutritional Supplement	Capsule	As per formula	N/A
Nifedipine IR	Nifetaj	Antihypertensive	Tablet	10 mg	Class II
Nitrofurantoin	Nitrotaj	Urinary Anti-Infective	Tablet	100 mg	Class IV
Nystatin	Nystataj	Antifungal	Tablet	500,000 IU	Class IV
Phenobarbital	Phenotaj	Antiepileptic / Sedative	Tablet	15 mg, 100 mg	Class I
Phenoxymethyl Penicillin (Penicillin V)	Penvitaj	Antibiotic	Tablet	250 mg, 500 mg	Class I
Primaquine Base	Primataj	Antimalarial	Tablet	7.5 mg	Class I
Retinol (Vitamin A)	Vitataj-A	Vitamin Supplement	Soft Gel Capsule	200,000 IU	Class II
Salbutamol	Salbutaj	Bronchodilator	Tablet	4 mg	Class I
Sulfamethoxazole + Trimethoprim	Cotritaj	Antibacterial	Tablet	400 mg + 80 mg	Class I
Sulfamethoxazole + Trimethoprim	Cotritaj-DS	Antibacterial	Dispersible Tablet	100 mg + 20 mg	Class I
Acetylsalicylic Acid (Aspirin)	Aspitaj	Antiplatelet / Analgesic	Tablet	100 mg, 500 mg	Class I
Activated Charcoal	Charcotaj	Antidote / Adsorbent	Tablet	500 mg	N/A
Aluminium Hydroxide + Magnesium Hydroxide	Antacitaj	Antacid	Chewable Tablet	200 mg + 200 mg	N/A
Calcium	Calcitaj	Mineral Supplement	Tablet	1 g	Class III
Chlorpheniramine Maleate	Chlorotaj	Antihistamine	Tablet	4 mg	Class I
Ciprofloxacin	Ciprotaj	Antibiotic (Fluoroquinolone)	Tablet	250 mg	Class III
Ergometrine Maleate	Ergotaj	Uterotonic	Tablet	0.2 mg	Class I
Famotidine	Famotaj	Antiulcer	Tablet	40 mg	Class III
Ferrous Sulfate + Folic Acid	Ferrofol-Taj	Hematinic	Tablet	60 mg + 400 mcg	N/A
Folic Acid	Folitaj	Vitamin Supplement	Tablet	5 mg	Class III
Ibuprofen	Ibutaj	NSAID	Tablet	200 mg	Class II
Metoclopramide Hydrochloride	Metotaj	Antiemetic	Tablet	10 mg	Class III
Nystatin Vaginal	Nystataj-V	Antifungal	Vaginal Tablet	100,000 IU	Class IV
Paracetamol	Parataj	Analgesic / Antipyretic	Tablet	100 mg, 500 mg	Class I
Zinc Dispersible	Zinctaj	Nutritional Supplement	Dispersible Tablet	20 mg	Class III

TAJ PHARMA – TOPICAL CREAMS / OINTMENTS / GELS

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class (Estimate)
Betamethasone + Neomycin	Betaneotaj	Corticosteroid + Antibiotic	Cream	0.1% + 0.5%	N/A
Chlorhexidine Digluconate Gel	Chlorotaj Gel	Antiseptic	Gel	7.1%	N/A
Lidocaine Gel	Lidotaj	Local Anesthetic	Gel	2%, 4%	N/A
Silver Sulfadiazine	Silvertaj	Burn Management	Cream	1%	N/A
Tetracycline Eye Ointment	Tetrataj Eye	Ophthalmic Antibiotic	Eye Ointment	1%	N/A
Zinc Oxide	Zinctaj Cream	Skin Protectant	Cream	20%	N/A

TAJ PHARMA – ORAL LIQUIDS / SUSPENSIONS

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class (Estimate)
Amoxicillin	Amoxtaj Dry Syrup	Antibiotic	Powder for Suspension	125 mg/5 ml, 250 mg/5 ml	Class I
Chloroquine	Chlorotaj Syrup	Antimalarial	Syrup	50 mg/5 ml	Class I
Erythromycin	Erythrotaj	Antibiotic	Dry Syrup	125 mg/5 ml	Class I
Ferrous Sulfate	Ferrotaj Syrup	Hematinic	Oral Solution	125 mg/5 ml	Class III
Ciprofloxacin	Ciprotaj Suspension	Antibiotic	Oral Suspension	250 mg/5 ml	Class III
Metronidazole	Metrotaj Suspension	Antiprotozoal	Suspension	200 mg/5 ml	Class I
Nystatin	Nystataj Suspension	Antifungal	Oral Suspension	100,000 IU/ml	Class IV
Paracetamol	Parataj Syrup	Analgesic / Antipyretic	Syrup	120 mg/5 ml	Class I
Salbutamol	Salbutaj Syrup	Bronchodilator	Syrup	2 mg/5 ml	Class I
Sulfamethoxazole + Trimethoprim	Cotritaj Suspension	Antibacterial	Oral Suspension	200 mg + 40 mg/5 ml	Class I
Aluminium Hydroxide + Magnesium Hydroxide	Antacitaj Suspension	Antacid	Suspension	225 mg + 200 mg/5 ml	N/A

Comprehensive Third-Party Pharmaceutical Manufacturing Solutions

Third-party manufacturing has emerged as one of the most effective business models for pharmaceutical companies seeking rapid expansion without substantial capital investment.

Our third-party manufacturing services offer:

Cost-Efficient Production

Companies can eliminate the need for large investments in manufacturing facilities, equipment, validation processes, and workforce management.

Scalable Manufacturing Capacity

We provide flexible production capabilities that accommodate:

• Small pilot batches
• Commercial-scale production
• Large-volume export requirements
• Market-specific product customization

Regulatory Compliance Assurance

All manufacturing operations follow internationally accepted quality systems, reducing compliance risks and supporting seamless product registrations.

Private Label and Contract Manufacturing

We offer customized solutions including:

• Brand-specific manufacturing
• Custom packaging
• Country-specific labeling
• Product customization
• Regulatory document support

This allows our partners to focus on marketing, distribution, and market expansion while we manage the complexities of pharmaceutical production.

---

Merchant Export Services Designed for Global Success

Merchant exports continue to play a critical role in international pharmaceutical trade. Through our specialized merchant export division, we support pharmaceutical importers, distributors, government tenders, NGOs, and healthcare organizations worldwide.

Our merchant export services include:

• Product sourcing
• Export documentation
• Regulatory support
• Logistics coordination
• Customs compliance
• Packaging adaptation
• Market-specific labeling

This comprehensive approach simplifies international procurement while ensuring timely product delivery and regulatory conformity.

---

Accelerate Registrations with 190 CTD Dossiers

One of the most significant challenges in international pharmaceutical expansion is the product registration process.

To address this challenge, we provide access to 190 Common Technical Document (CTD) dossiers covering both pharmaceutical and nutraceutical products.

These dossiers offer substantial advantages:

Faster Market Entry

Regulatory submissions can be initiated more quickly, reducing approval timelines.

Reduced Development Costs

Partners benefit from ready-to-use documentation, eliminating the need for costly dossier preparation from scratch.

Regulatory Confidence

Professionally prepared CTD dossiers support smoother interactions with health authorities and regulatory agencies.

Broader Product Opportunities

A diverse dossier portfolio allows partners to select products aligned with local market demands and therapeutic priorities.

This extensive regulatory resource represents a valuable asset for companies seeking immediate growth opportunities.

---

Access to 1019 COPPs for International Registrations

Certificates of Pharmaceutical Product (COPPs) remain essential for many international registration procedures.

Our portfolio includes access to 1019 COPPs, supporting pharmaceutical registrations across numerous global markets.

Key benefits include:

• Simplified registration processes
• Faster documentation availability
• Enhanced regulatory acceptance
• Improved market access opportunities
• Reduced administrative burdens

By providing comprehensive regulatory support, we help partners navigate complex approval pathways with greater efficiency and confidence.

---

350+ Approved Formulations Across Major Therapeutic Segments

Product portfolio strength is a critical factor in achieving sustainable pharmaceutical growth.

We offer more than 350 approved pharmaceutical formulations, covering a wide range of therapeutic categories.

Our portfolio includes:

Cardiovascular Products

Cardiovascular diseases continue to represent one of the largest therapeutic markets globally.

Our cardiovascular portfolio includes formulations designed to address:

• Hypertension
• Heart failure
• Dyslipidemia
• Antiplatelet therapy
• Anticoagulation management
• Cardiac support therapies

Neuropsychiatry Products

Mental health and neurological disorders are receiving increasing healthcare attention worldwide.

Our neuropsychiatry portfolio includes therapies targeting:

• Anxiety disorders
• Depression
• Schizophrenia
• Bipolar disorder
• Neuropathic conditions
• Epilepsy management

Additional Therapeutic Categories

Beyond cardiovascular and neuropsychiatry expertise, we offer products across multiple healthcare segments, including:

• Anti-infectives
• Gastrointestinal medicines
• Respiratory therapies
• Analgesics
• Anti-diabetics
• Nutraceuticals
• Vitamins and minerals
• Women’s healthcare
• Pediatric formulations

This diverse portfolio enables partners to build comprehensive market offerings while addressing evolving healthcare needs.

---

Comprehensive Regulatory and Documentation Support

Successful pharmaceutical exports require extensive documentation and regulatory compliance.

Our regulatory support services include:

• CTD dossier availability
• COPP documentation
• Product specifications
• Certificates of Analysis
• Stability data support
• Manufacturing licenses
• GMP certifications
• Product registration assistance

These resources help reduce regulatory complexity and facilitate successful market approvals.

---

End-to-End Marketing Support for International Partners

A successful market launch extends beyond manufacturing.

To support our partners’ commercial success, we provide:

Professional Visual Aids

High-quality promotional materials designed to support product positioning and healthcare professional engagement.

Labeling and Packaging Support

Country-specific:

• Labels
• Cartons
• Product inserts
• Artwork development

Product Samples

Cost-effective sample support enables distributors and marketing teams to evaluate products before large-scale procurement.

Brand Development Assistance

We collaborate with partners to ensure products are professionally presented and aligned with local market expectations.

This integrated support model strengthens market entry efforts and enhances commercial outcomes.

---

Why Asian and African Markets Represent Significant Growth Opportunities

Asia and Africa remain among the fastest-growing pharmaceutical markets globally.

Several factors continue to drive demand:

• Expanding populations
• Urbanization
• Improved healthcare access
• Government healthcare initiatives
• Growing middle-class populations
• Increased chronic disease prevalence
• Rising pharmaceutical consumption

Companies entering these markets with quality-assured products and strong regulatory support can establish substantial competitive advantages.

Our strategic partnership model is specifically designed to help businesses capitalize on these emerging opportunities while minimizing operational risks.

---

Building Long-Term Pharmaceutical Success Through Collaboration

The future of pharmaceutical growth lies in strategic collaboration, operational excellence, and regulatory readiness. Companies that align with experienced manufacturing partners gain access to valuable resources, accelerated market entry pathways, and scalable growth opportunities.

With a WHO-GMP, GLP, and RCMC certified manufacturing facility, access to 190 CTD dossiers, 1019 COPPs, and a portfolio of 350+ approved formulations, we provide a complete platform for international pharmaceutical expansion.

Whether your objective is third-party manufacturing, merchant exports, private labeling, or international product registrations, our comprehensive solutions are designed to support sustainable growth across Asia, Africa, and other emerging markets.

By combining manufacturing excellence, regulatory expertise, and commercial support, we help transform pharmaceutical opportunities into long-term business success.