CTD Dossier & COPP-Ready List: Comprehensive Guide for Semi-Regulated Pharmaceutical Markets

The global pharmaceutical industry is increasingly expanding into semi-regulated markets, where regulatory harmonization and efficient dossier preparation are essential for success. At Taj Pharma, we are proud to offer a complete portfolio of CTD (Common Technical Document) and COPP (Certificate of Pharmaceutical Product) ready formulations that meet WHO, PIC/S, and country-specific requirements.

This detailed article highlights our CTD Dossier & COPP-Ready Product List, providing all relevant data — including Product Name, Brand Name, Therapeutic Category, Dosage Form, Available Strengths, and BCS Classification — ideal for partners, licensing authorities, and distributors seeking quality-assured products.


What is a CTD Dossier and COPP?

A CTD Dossier is a harmonized regulatory submission format defined by the International Council for Harmonisation (ICH), which standardizes the presentation of quality, safety, and efficacy data across global markets. It is divided into five modules:

  1. Module 1: Administrative and regional information
  2. Module 2: Quality, non-clinical, and clinical summaries
  3. Module 3: Quality data including formulation, stability, and specifications
  4. Module 4: Non-clinical study reports
  5. Module 5: Clinical study reports

The COPP (Certificate of Pharmaceutical Product), issued under the WHO certification scheme, certifies that a pharmaceutical product is authorized for marketing in the country of origin and is manufactured according to Good Manufacturing Practices (GMP). It plays a critical role in product registration across semi-regulated and developing markets.


Comprehensive CTD Dossier & COPP-Ready Product Portfolio

Below is the list of fully CTD Dossier and COPP-ready pharmaceutical formulations developed and manufactured by Taj Pharma India Ltd, with complete technical data and documentation support.

Product NameBrand NameTherapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
Atenolol & ChlorthalidonePANAM MiteAntihypertensive (Beta-blocker + Diuretic)Tablet100 mg / 25 mgAtenolol: BCS III; Chlorthalidone: BCS IV
BedaquilineHANSEN (Thailand / Kazakhstan / Global)Antimycobacterial (Anti-TB)Tablet100 mgBCS II
ChlorthalidoneRekiyaDiuretic / AntihypertensiveTablet25 mgBCS IV
DapagliflozinDAPLIXAntidiabetic (SGLT2 Inhibitor)Tablet10 mgBCS II
Dolutegravir SodiumDOLUTRIX / TAPIVIRAntiretroviral (INSTI)Tablet50 mgBCS II
Glyceryl Trinitrate—Antianginal (Nitrate)Sublingual Tablet0.5 mgNon-BCS (sublingual use)
HydrocortisoneLADEX CORTEF (Thailand)CorticosteroidTablet5 mgBCS I
IvermectinIVEROTAJ (Lebanon / Thailand)AntiparasiticTablet6 mgBCS II
Mefloquine Hydrochloride— (Malaysia)AntimalarialTablet250 mgBCS II
Micronized Purified Flavonoid FractionVENOSTOR 500Venoactive / PhlebotonicTablet500 mgNot Applicable
PenicillaminePENICI–D (Thailand)Chelating AgentCapsule250 mgBCS I/II
Prazosin HydrochloridePRAZOTAJ 1Antihypertensive (Alpha-blocker)Tablet1 mgBCS II
PrednisoloneSYNTACORTCorticosteroid (Anti-inflammatory)Tablet10 mgBCS I
Pyrimethamine—Antiprotozoal / AntimalarialTablet25 mgBCS II
Sacubitril & ValsartanSACUBVALTAJ 100 / 200Heart Failure (ARNI)Tablet100 mg / 200 mgSacubitril: I/II; Valsartan: II
Sitagliptin + Metformin (ER)SITAMORFIN 50/1000, SITAMORFIN 50/500Antidiabetic (DPP-4 Inhibitor + Biguanide)Extended Release Tablet50 mg/1000 mg, 50 mg/500 mgSitagliptin: I; Metformin: III
SitagliptinSITAFOS 100 / SITAFOS 50Antidiabetic (DPP-4 Inhibitor)Tablet100 mg / 50 mgBCS I
Sofosbuvir + VelpatasvirHEPCITAJ V / VIRALSOFAntiviral (HCV)Tablet400 mg + 100 mgSofosbuvir: I; Velpatasvir: II
SofosbuvirHEPCITAJAntiviral (HCV)Tablet400 mgBCS I
TacrolimusTACROTAJ 0.5 / TACROTAJ 1ImmunosuppressantCapsule0.5 mg / 1 mgBCS II
Warfarin SodiumRIFATAJ 1 / RIFATAJ 3AnticoagulantTablet1 mg / 3 mgBCS I/II

Key Therapeutic Segments and Export Relevance

1. Cardiovascular and Antihypertensive Range

Our cardiovascular range — including Atenolol & Chlorthalidone, Prazosin, and Sacubitril & Valsartan — is manufactured under WHO-cGMP certification and fully supported by stability studies, bioequivalence data, and quality validation protocols. These products are widely exported to semi-regulated markets in Asia, Africa, CIS, and Latin America.

2. Antimicrobial, Antiviral, and Antiparasitic Range

The Bedaquiline, Dolutegravir, Sofosbuvir, and Ivermectin product lines are COPP-certified and registered with multiple MOHs. These formulations are compliant with WHO prequalification standards, ensuring high therapeutic efficacy and global acceptance.

3. Antidiabetic Formulations

Our Sitagliptin, Metformin, and Dapagliflozin formulations cater to the growing demand for chronic metabolic disorder management. They are designed for optimal bioavailability, controlled release, and patient compliance, supported by full CTD Module 3 documentation.

4. Steroidal and Anti-inflammatory Products

Products such as Hydrocortisone and Prednisolone are manufactured in dedicated cleanrooms under stringent microbiological controls. Each dossier includes validated analytical methods, stability studies, and compliance with USP/Ph. Eur. standards.

5. Antimalarial and Antiprotozoal Range

Mefloquine, Pyrimethamine, and Penicillamine capsules are produced in line with WHO’s GMP guidelines and tested for dissolution, assay, uniformity, and stability across tropical conditions, making them ideal for export to malaria-endemic regions.


Advantages of Taj Pharma’s CTD & COPP-Ready Products

  1. WHO-GMP, PIC/S, and ISO Certified Manufacturing Facility at Sarigam, Gujarat (India).
  2. Comprehensive CTD Modules (1–5) for all solid oral formulations, ensuring seamless registration.
  3. Rapid dossier submission support with administrative and quality sections pre-compiled.
  4. Validated manufacturing processes with full-scale analytical method validation and stability data.
  5. Regulatory compliance for export to semi-regulated and emerging markets including Africa, Southeast Asia, CIS, Middle East, and Latin America.
  6. Bioequivalence data availability for key molecules such as Sofosbuvir, Sitagliptin, and Dolutegravir.
  7. COPP certification from the Indian FDA and Ministry of Health, ensuring authenticity and market readiness.

Regulatory Documentation and Support

Taj Pharma provides comprehensive regulatory documentation, including:

  • COPP and Free Sale Certificates (FSC) from the licensing authority
  • Product registration dossiers in CTD/eCTD formats
  • Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
  • Specifications and validated analytical methods
  • Stability data (Zone IVb, 30°C/75% RH)
  • Process validation and cleaning validation reports
  • GMP Certificates, Site Master File, and Quality Agreements

Each dossier is meticulously prepared and aligned with WHO and ICH Q-series guidelines to ensure technical accuracy, completeness, and regulatory acceptance.


Commitment to Quality and Global Compliance

Our commitment goes beyond product supply — we ensure regulatory reliability, quality assurance, and consistent documentation. Taj Pharma’s dossier department continuously updates CTD submissions according to country-specific requirements, ensuring that partners receive market-ready and compliant dossiers without delays.

All products listed in our CTD Dossier & COPP-Ready List are manufactured under strict GMP protocols, ensuring uniform quality, stability, and efficacy that meet international benchmarks.


With a robust manufacturing infrastructure, regulatory expertise, and a portfolio of globally accepted formulations, Taj Pharma stands as a trusted partner for licensing, registration, and contract manufacturing in semi-regulated markets. Our CTD Dossier and COPP-ready products simplify international registration and accelerate market access for our partners worldwide.

If you are looking for reliable, high-quality, and regulatory-compliant formulations, Taj Pharma’s dossier-ready portfolio is your gateway to seamless global pharmaceutical success.