GMP Certified Pharmaceutical Manufacturing for Bosnia and Herzegovina

EU-GMP certified pharma manufacturer in Gujarat
TAJ PHARMA

We present Taj Pharma India Ltd. as a strategic contract manufacturing and registration partner for Bosnia and Herzegovina, offering EU-GMP compliant finished dosage forms, robust regulatory support, and long-term supply reliability. Our manufacturing operations are built to meet the highest international standards, enabling seamless market access for regulated European and Balkan markets.

With a proven export footprint across LATAM, Africa, CIS, and Southeast Asia, we deliver consistent quality, regulatory-ready documentation, and scalable commercial supply models designed for sustainable growth in Bosnia and Herzegovina.


Immediate Partnership Opportunities – EU-GMP Finished Dosage Forms

We offer ready-to-commercialize pharmaceutical products manufactured at our EU-GMP aligned Unit-01 facility, supported by validated processes, stability data, and complete regulatory documentation.

Available Products for Bosnia and Herzegovina

  • Levetiracetam Tablets
  • Gabapentin Capsules
  • Pyridostigmine Tablets

These products address high-demand neurological and neuromuscular therapeutic categories, making them ideal for hospital procurement programs, institutional tenders, and long-term chronic therapy markets.

Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
Amoxycillin + Potassium Clavulanate for InjectionTAJ-CLAVINJECTAntibiotic (Beta-lactam)Injection600 mgBCS III
Cefepime for Injection IPTAJ-CEFEPIMECephalosporin AntibioticInjection1 gBCS III
Ceftazidime for Injection IPTAJ-CEFTAZCephalosporin AntibioticInjection1 gBCS III
Ceftriaxone + Sulbactam for InjectionTAJ-TRIASULBCephalosporin + BLIInjection375 mgBCS III
Cefoperazone Sodium Injection IPTAJ-CEFOPERACephalosporin AntibioticInjection1 gBCS III
Ceftriaxone Injection IPTAJ-TRIAXONECephalosporin AntibioticInjection500 mgBCS III
Ceftriaxone + Sulbactam for InjectionTAJ-TRIASULBCephalosporin + BLIInjection750 mgBCS III
Cefoperazone + Sulbactam for InjectionTAJ-CEFOSULBCephalosporin + BLIInjection2 gBCS III
Rabeprazole Sodium + Levosulpride SRTAJ-RABLEVO SRGastrointestinalCapsules20/75 mgBCS II/III
Betamethasone Valerate + Neomycin CreamTAJ-BETNEODermatologyCream20 gBCS N/A
Phenobarbital Tablets USPTAJ-PHENOAntiepilepticTablets30 mgBCS I
Phenobarbital Tablets USPTAJ-PHENOAntiepilepticTablets60 mgBCS I
Olanzapine Tablets USPTAJ-OLANZAntipsychoticTablets10 mgBCS II
Micronized Purified Flavanoid FractionTAJ-MPFFVascular TonicTablets500 mgBCS III
Amoxicillin Oral SuspensionTAJ-AMOX SUSPAntibioticSuspension250 mg/5 mlBCS III
Sumatriptan Tablets USPTAJ-SUMATRIPAnti-migraineTablets50 mgBCS III
Piperacillin + Tazobactam for InjectionTAJ-PIPTAZAntibioticInjection4.5 gBCS III
Ceftriaxone + Sulbactam for InjectionTAJ-TRIASULBCephalosporin + BLIInjection1.5 g/vialBCS III
Meropenem for InjectionTAJ-MEROPENCarbapenem AntibioticInjection1 gBCS III
Piperacillin + Tazobactam for Injection USPTAJ-PIPTAZAntibioticInjection2.25 gBCS III
Cefoperazone + Sulbactam for InjectionTAJ-CEFOSULBCephalosporin + BLIInjection1 gBCS III
Ceftazidime for Injection IPTAJ-CEFTAZCephalosporin AntibioticInjection1000 mgBCS III
Colistimethate Sodium for Injection IPTAJ-COLISTPolymyxin AntibioticInjection3 MIUBCS III
Colistimethate Sodium for Injection IPTAJ-COLISTPolymyxin AntibioticInjection1 MIUBCS III
Colistimethate Sodium for Injection IPTAJ-COLISTPolymyxin AntibioticInjection2 MIUBCS III
Valganciclovir Tablets USPTAJ-VALGANAntiviralTablets450 mgBCS II
Ginkgo Biloba Film Coated TabletsTAJ-GINKGOHerbal SupplementTablets40 mgBCS N/A
Cefuroxime Axetil Tablets IPTAJ-CEFUROCephalosporin AntibioticTablets500 mgBCS II
Amoxycillin Trihydrate Tablets IPTAJ-AMOXAntibioticTablets500 mgBCS III
Amoxycillin Trihydrate Tablets IPTAJ-AMOXAntibioticTablets1000 mgBCS III
Amoxycillin + Potassium Clavulanate Tablets IPTAJ-CLAVTABAntibioticTablets1000 mgBCS III
Mesalamine Prolonged Release TabletsTAJ-MESAPRGastrointestinalTablets1.2 gBCS II
Pantoprazole for InjectionTAJ-PANTINJProton Pump InhibitorInjection40 mgBCS II
Mesalazine PelletsTAJ-MESAPELGastrointestinalPellets1 gBCS II
Diethylcarbamazine Citrate Tablets USPTAJ-DECAnthelminticTablets100 mgBCS I
Bisoprolol + Amlodipine TabletsTAJ-BISAMLOCardiovascularTablets5/5 mgBCS II
Dapsone Tablets USPTAJ-DAPAntibioticTablets100 mgBCS II
Venlafaxine Hydrochloride ER CapsulesTAJ-VENLA ERAntidepressantCapsules150 mgBCS I
Glimepiride + Metformin SR TabletsTAJ-GLIMET SRAntidiabeticTablets1/500 mgBCS II/III
Glimepiride + Metformin SR TabletsTAJ-GLIMET SRAntidiabeticTablets2/500 mgBCS II/III
Glimepiride + Metformin SR TabletsTAJ-GLIMET SRAntidiabeticTablets1/1000 mgBCS II/III
Irinotecan Hydrochloride ConcentrateTAJ-IRINOAnticancerInjection20 mg/ml (2 ml)BCS IV
Irinotecan Hydrochloride ConcentrateTAJ-IRINOAnticancerInjection20 mg/ml (15 ml)BCS IV
Tapentadol ER TabletsTAJ-TAPENTA ERAnalgesicTablets50 mgBCS II
Tapentadol ER TabletsTAJ-TAPENTA ERAnalgesicTablets100 mgBCS II
Tapentadol ER TabletsTAJ-TAPENTA ERAnalgesicTablets150 mgBCS II
Tapentadol ER TabletsTAJ-TAPENTA ERAnalgesicTablets200 mgBCS II
Pantoprazole + Domperidone SR CapsulesTAJ-PANTDOM SRGastrointestinalCapsules40/30 mgBCS II/III
Ferrous Ascorbate + Folic Acid + Cyanocobalamin SyrupTAJ-FERPLUSHematinicSyrupStandardBCS III
Alprazolam Tablets USPTAJ-ALPRAAnxiolyticTablets1 mgBCS II
Human Normal Immunoglobulin IPTAJ-HNIGImmunologicalInjection5%BCS N/A
Zinc Oxide Ointment USPTAJ-ZINCODermatologyOintment20 gBCS N/A
Mesalamine SuppositoriesTAJ-MESASUPGastrointestinalSuppository500 mgBCS II
Irbesartan Tablets USPTAJ-IRBEAntihypertensiveTablets300 mgBCS II
Ramelteon Film Coated TabletsTAJ-RAMELHypnoticTablets8 mgBCS II
Piribedil SR TabletsTAJ-PIRIBED SRNeurologyTablets50 mgBCS II
Feracrylum SolutionTAJ-FERACRYLHemostaticSolution1%BCS N/A
Atovaquone + Proguanil TabletsTAJ-ATOPROAntimalarialTablets250/100 mgBCS II/IV
Naltrexone + Bupropion PR TabletsTAJ-NALBUP PRWeight ManagementTablets8/90 mgBCS II
Trimethoprim TabletsTAJ-TRIMAntibioticTablets200 mgBCS III
Zolmitriptan TabletsTAJ-ZOLMITAnti-migraineTablets2.5 mgBCS III
Zolmitriptan TabletsTAJ-ZOLMITAnti-migraineTablets5 mgBCS III
Potassium Iodide Tablets USPTAJ-KIODEndocrineTablets130 mgBCS I
Itraconazole CapsulesTAJ-ITRACAPAntifungalCapsules100 mgBCS II
Posaconazole GR TabletsTAJ-POSAGRAAntifungalTablets100 mgBCS II
Miltefosine CapsulesTAJ-MILTEAntileishmanialCapsules50 mgBCS II
Doxycycline + Lactic Acid Bacillus CapsulesTAJ-DOXYLACAntibiotic + ProbioticCapsules100 mg + 5B sporesBCS I/III

Key Product Highlights

  • All strengths available
  • Ready regulatory dossiers
  • Valid bioequivalence (BE) studies
  • US FDA-approved manufacturing facility
  • Stability data available for Zone II & Zone IVb
  • Multiple pack styles supported with product-specific shelf life
  • MOQ: 100,000 tablets or capsules per strength
  • Commercial-scale production capacity
  • Dedicated product-specific quality control protocols

Each formulation is developed using validated excipients, pharmacopeial-grade APIs, and internationally benchmarked quality standards to ensure therapeutic equivalence, patient safety, and regulatory acceptance.


Manufacturing Excellence – WHO-GMP, EU-GMP, and PIC/S Aligned

Our manufacturing infrastructure is engineered to meet European regulatory expectations, ensuring seamless dossier acceptability for Bosnia and Herzegovina.

Certifications and Compliance:

  • WHO-GMP Certified
  • ISO 9001:2018
  • PIC/S Aligned
  • US FDA Inspected Facility
  • GLP-Compliant Quality Control Systems

Our facilities operate under a validated Quality Management System (QMS), incorporating:

  • Environmental monitoring programs
  • Process validation protocols
  • Cleaning validation and equipment qualification
  • Data integrity controls
  • Change control and deviation management
  • Batch traceability and pharmacovigilance reporting

Regulatory & Commercial Framework for Bosnia and Herzegovina

We offer a structured and transparent regulatory-commercial engagement model for Balkan and EU-adjacent markets.

Regulatory Structure

  • Taj Pharma remains the Marketing Authorization (MA) Holder, ensuring consistent quality ownership and regulatory accountability.
  • We provide complete dossiers in CTD format for streamlined local registration.
  • Regulatory technical support for:
    • Company registration
    • Product registration
    • Local labeling compliance
    • Stability commitments
    • Post-approval variations

Commercial Partnership Model

  • Exclusive, country-dedicated distribution rights for Bosnia and Herzegovina
  • Open to regional Balkan or EU extension rights, subject to performance milestones
  • Ready to sign:
    • Distribution Agreements
    • Exclusivity Agreements
    • LSA (License and Supply Agreements)
  • Flexible pricing frameworks aligned with:
    • Institutional procurement
    • Hospital tenders
    • Public reimbursement programs

High-Demand Therapeutic Categories

Neurology & Epilepsy Management

Levetiracetam Tablets

  • Broad-spectrum antiepileptic agent
  • High prescription demand in neurology clinics
  • Long-term therapy compliance profile
  • Supported by BE data and stability studies

Neuropathic Pain & CNS Therapy

Gabapentin Capsules

  • Widely prescribed for neuropathic pain
  • Strong institutional tender demand
  • Stable chronic therapy profile
  • Multiple strength configurations

Neuromuscular Disorders

Pyridostigmine Tablets

  • First-line therapy for myasthenia gravis
  • Hospital procurement essential medicine
  • Consistent public sector demand
  • Proven stability and regulatory-ready formulation

Stability & Shelf-Life Assurance

All products are supported by long-term and accelerated stability data under:

  • Zone II (25°C / 60% RH)
  • Zone IVb (30°C / 75% RH)

We offer:

  • Product-specific shelf life commitments
  • Ongoing stability programs
  • Extension-ready data packages
  • Post-approval stability continuation protocols

Flexible Packaging & Commercial Customization

We provide multiple pack styles to meet regulatory and commercial needs:

  • Alu-Alu blister packs
  • PVC-PVDC blister packs
  • HDPE bottles
  • Institutional bulk packs
  • Patient compliance packs

Customization includes:

  • Country-specific labeling
  • Multilingual pack inserts
  • Braille embossing
  • Serialization-ready packaging
  • Tamper-evident seals

Supply Chain Reliability & Production Scalability

We operate a vertically integrated manufacturing and supply chain ecosystem, ensuring uninterrupted supply continuity.

Operational Strengths:

  • Dedicated export production lines
  • Advanced production planning systems
  • API sourcing diversification
  • Buffer inventory protocols
  • Batch size scalability
  • Emergency replenishment capability

Our production capacity supports both initial market entry volumes and long-term institutional supply growth.


Regulatory Support & Dossier Readiness

We deliver full regulatory technical packages for Bosnia and Herzegovina, including:

  • CTD Modules 1–5
  • BE study reports
  • Method validation reports
  • Stability study reports
  • GMP certificates
  • Batch manufacturing records
  • API DMF support
  • Risk management plans

Our regulatory team ensures rapid dossier adaptation to local authority requirements.


Pharmacovigilance & Post-Marketing Surveillance

We maintain globally aligned pharmacovigilance systems to support:

  • Adverse event reporting
  • Signal detection
  • Periodic safety update reports (PSURs)
  • Risk mitigation strategies
  • Regulatory authority reporting

This ensures long-term patient safety compliance in Bosnia and Herzegovina.


Commercial Economics for Emerging European Markets

We deliver cost-competitive EU-GMP quality medicines, enabling:

  • Affordable healthcare budgets
  • Institutional tender competitiveness
  • Long-term supply contracts
  • Sustainable pricing models

By leveraging India’s manufacturing scale, we provide high-quality medicines at optimized cost structures.


Strategic Partnership Inputs Requested

To initiate the partnership roadmap, we invite inputs on:

  • Upcoming government and institutional tenders
  • Company registration plan in Bosnia and Herzegovina
  • Product registration roadmap and timelines
  • Commercial interest details, including:
    • Annual buying volume
    • Target price / expected transfer price
    • Required pack style
    • 3–5 year demand forecast

Why Taj Pharma is the Preferred Contract Manufacturing Partner

  • EU-GMP aligned manufacturing
  • Ready dossiers with BE studies
  • US FDA-approved facility
  • Scalable production capacity
  • Regulatory technical expertise
  • Flexible exclusivity frameworks
  • Institutional tender experience
  • Cost-optimized supply models
  • Long-term partnership philosophy

Company Profile – Taj Pharma India Ltd.

Taj Pharma India Ltd.
Plot No. 1019, Vill. Sarigam
G.I.D.C., Road No. 10
Dist. Valsad, Gujarat, India 396155

Certifications: WHO-GMP, ISO 9001:2018, PIC/S, GLP compliant
Manufacturing Facility: US FDA Inspected

Contact Details:
Call: +91 84484 44095
Call / WhatsApp: +91 7400009975 / +91 7400009976
Email: info@tajpharma.com
Website: www.tajpharmaindia.com


Long-Term Growth Partnership for Bosnia and Herzegovina

We are committed to establishing a long-term, transparent, and growth-oriented pharmaceutical partnership for Bosnia and Herzegovina. Our operational philosophy is rooted in regulatory integrity, quality excellence, ethical business conduct, and commercial sustainability.

We welcome discussions to advance product registration, institutional tender participation, and exclusive market development strategies.