Contract Manufacturing and In-Licensing of Finished Pharmaceutical Products for Malaysia

Strategic Contract Manufacturing Solutions for the Malaysian Pharmaceutical Market

State-of-the-art facility in Sarigam GIDC
State-of-the-art Pharma Production Facility in Sarigam GIDC

We present a comprehensive contract manufacturing and in-licensing portfolio of finished pharmaceutical products specifically aligned for registration, commercialization, and sale in Malaysia. Our offerings are structured to meet PIC/S-aligned GMP expectations, Stability Zone IV-B requirements, and Certificate of Pharmaceutical Product (CoPP) availability, ensuring smooth regulatory acceptance and rapid market entry.

Our manufacturing ecosystem supports regulated and semi-regulated markets, with strong compliance to PIC/S, USFDA, MHRA, TGA, EU-GMP, and ANVISA standards, making us an ideal import manufacturing partner for Malaysia.

This portfolio focuses primarily on products where Bioequivalence (BE) studies are NOT required, enabling faster licensing timelines, lower development costs, and reduced regulatory complexity, while still maintaining the highest quality and therapeutic reliability.


Taj Pharma Standard Product Listing Format – Malaysia Focus

Below is the structured product list in Taj Pharma’s standard technical format, designed for regulatory review, in-licensing discussions, and distributor evaluation.


Finished Pharmaceutical Products – BE Study NOT Required

Dermatology, Anti-Infective, Analgesic & Allergy Segment

Generic NameDosage FormAvailable Strengths / Pack SizeTherapeutic CategoryBCS Class (Estimate)
Clindamycin PhosphateGel1% w/w, 10 g / 20 gTopical AntibioticBCS Class I
IbuprofenOral Suspension100 mg/5 ml, 200 mg/5 ml; 60 ml / 100 mlNSAID / AnalgesicBCS Class II
DexamethasoneOral Paste1 mg/g; 2 g / 5 gCorticosteroidBCS Class I
Mometasone FuroateCream0.1% w/w; 15 gTopical CorticosteroidBCS Class I
Lidocaine + Triamcinolone Acetonide + Chlorhexidine HClGelStandard combination; 2–8 gOral Anti-Inflammatory / AntisepticBCS Class I
DesloratadineSyrup0.5 mg/ml; 60 ml / 100 mlAntihistamineBCS Class I
LoratadineSyrup1 mg/ml or 5 mg/5 ml; 60 ml / 100 mlAntihistamineBCS Class II
AlbendazoleTablet200 mg; 2 tablets/blisterAnthelminticBCS Class II
AlbendazoleOral Suspension200 mg/5 ml; 10 ml or equivalentAnthelminticBCS Class II
Paracetamol + CaffeineTablet500mg + 65 mg; 6–10 tablets/blisterAnalgesic / AntipyreticBCS Class I

Gastrointestinal Segment – Antacid Combination

3-in-1 Antacid Formulation

Composition Range:

  • Aluminium Hydroxide: 200–400 mg
  • Magnesium Hydroxide: 200–400 mg
  • Simethicone: 25–50 mg
Dosage FormPackaging FormatTherapeutic CategoryBCS Class (Estimate)
LiquidSachet & BottleAntacid / AntiflatulentNot Applicable
Chewable TabletBlister / StripAntacid / AntiflatulentNot Applicable

Gastrointestinal & Detoxification Products

Generic NameDosage FormAvailable Strengths / Pack SizeTherapeutic CategoryBCS Class (Estimate)
Activated CharcoalTablet250mg; 500mg; 10 tablets/blisterAdsorbent / Detoxifying AgentNot Applicable

ENT, Pain Management & Anti-Inflammatory Segment

Generic NameDosage FormAvailable Strengths / Pack SizeTherapeutic CategoryBCS Class (Estimate)
Benzydamine HCl + Cetylpyridinium ChlorideLozenge3 mg + standard CPC; any pack sizeOral Anti-Inflammatory / AntisepticBCS Class I
EsflurbiprofenPlaster / Patch40 mg; 6 patches or equivalentNSAID / Pain ManagementNot Applicable
KetoprofenPlaster / Patch30 mg; 6 patches or equivalentNSAID / Pain ManagementNot Applicable

Ophthalmic Pharmaceutical Products

Generic NameDosage FormStrengthTherapeutic CategoryBCS Class (Estimate)
Dexamethasone Sodium Phosphate + Neomycin SulphateEye Drops0.1% w/v + 0.5% w/vOphthalmic Anti-Infective / SteroidBCS Class I

Medical Devices – ISO 13485 Compliant

Ophthalmic Lubricant Products

CompositionDosage FormTherapeutic CategoryRegulatory Classification
Carboxymethylcellulose 0.5% + Glycerin 1.0% + Sodium Hyaluronate 0.1%Eye DropsOcular Lubricant / Dry Eye TherapyMedical Device (ISO 13485)

Hormonal Product – BE Study Required

Generic NameDosage FormStrength / Pack SizeTherapeutic CategoryBCS Class (Estimate)
LevonorgestrelTablet1.5 mg; 1 tabletEmergency ContraceptiveBCS Class I

Regulatory and Quality Compliance for Malaysia

All products listed above are developed and manufactured under internationally recognized GMP frameworks, fulfilling critical Malaysian regulatory expectations:

  • PIC/S-Aligned GMP Manufacturing
  • Stability Data – Zone IV-B
  • CoPP Availability
  • CTD/ACTD Dossier Readiness
  • Pharmacovigilance & Lifecycle Management Support
  • Flexible Branding, Private Label, and In-Licensing Options

Our facilities are designed to support high-volume commercial supply, government tenders, hospital channels, and retail pharmacy networks across Malaysia.


Why Partner With Us for Malaysia Contract Manufacturing

  • Strong PIC/S Compliance for Malaysian Registration
  • BE-Exempt Portfolio for Faster Market Entry
  • Broad Therapeutic Coverage
  • Flexible Pack Sizes and Market-Specific Artwork
  • Medical Device Manufacturing under ISO 13485
  • End-to-End Regulatory and Technical Support
  • Scalable Production with Long-Term Supply Assurance

We position ourselves as a strategic long-term manufacturing and in-licensing partner, ensuring regulatory confidence, commercial continuity, and sustainable growth in the Malaysian pharmaceutical market.