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India's ezetimibe imports from SOUTH AFRICA total $252 across 2 shipments from 2 foreign suppliers. RBC PHARMACEUTICALS PTY LTD leads with $248 in import value; the top 5 suppliers together control 100.0% of this origin. Leading Indian buyers include MSN LABORATORIES PRIVATE LIMITED. This corridor reflects India's pharmaceutical import demand for ezetimibe โ a concentrated sourcing relationship with select suppliers from SOUTH AFRICA.

RBC PHARMACEUTICALS PTY LTD is the leading Ezetimibe supplier from SOUTH AFRICA to India, with import value of $248 across 1 shipments. The top 5 suppliers โ RBC PHARMACEUTICALS PTY LTD, D.I. MEDICINE REGULATORY CONSULTANTS(D.I.PHARMACEU โ collectively account for 100.0% of total import value from this origin.
Ranked by import value (USD) ยท Indian Customs (DGFT) data
| # | Supplier | Value (USD) | Shipments | Share |
|---|---|---|---|---|
| 1 | RBC PHARMACEUTICALS PTY LTD | $248 | 1 | 98.6% |
| 2 | D.I. MEDICINE REGULATORY CONSULTANTS(D.I.PHARMACEU | $4 | 1 | 1.4% |
Ranked by import value (USD)
| # | Buyer | Value (USD) | Shipments | Share |
|---|---|---|---|---|
| 1 | MSN LABORATORIES PRIVATE LIMITED | $252 | 2 | 100.0% |
SOUTH AFRICA โ India trade corridor intelligence
The South Africa to India trade corridor is currently stable, with no significant port congestion reported at major Indian ports such as Jawaharlal Nehru Port Trust (JNPT), Chennai, and Mundra. Freight rates have remained consistent over the past year. The exchange rate between the South African Rand (ZAR) and the Indian Rupee (INR) has experienced minor fluctuations, with the ZAR strengthening slightly against the INR.
The Production Linked Incentive (PLI) scheme introduced by the Indian government aims to boost domestic manufacturing and reduce import dependency. This policy may impact the volume of finished formulation imports from South Africa, as domestic production increases. Import substitution policies are being evaluated to encourage local production of pharmaceutical products, potentially affecting the demand for imports.
India and South Africa maintain a strong trade relationship, with ongoing negotiations to enhance bilateral trade, including the pharmaceutical sector. Discussions focus on mutual recognition of Good Manufacturing Practice (GMP) standards and facilitating smoother trade procedures. These efforts aim to strengthen the pharmaceutical trade corridor and ensure the availability of quality medicines in both countries.
The landed cost of importing finished Ezetimibe formulations from South Africa to India includes the following components:
The per-unit landed cost is calculated by summing these components and dividing by the total number of units imported.
CDSCO registration, import licensing, and quality testing requirements
To import finished pharmaceutical formulations containing Ezetimibe (HS Code 30049099) into India, the Central Drugs Standard Control Organization (CDSCO) mandates that both the importer and the product be registered. The importer must obtain an Import License from the Directorate General of Foreign Trade (DGFT), which requires a valid Importer Exporter Code (IEC). The product must be registered with CDSCO, necessitating submission of Form 40/41, along with a No Objection Certificate (NOC) from the manufacturer. The registration process includes providing a Certificate of Pharmaceutical Product (CoPP), Good Manufacturing Practice (GMP) certificate, and stability data compliant with ICH Zone IV guidelines. The timeline for import drug registration varies but typically ranges from 6 to 12 months, depending on the completeness of the application and regulatory workload. For Ezetimibe formulations, specific requirements include detailed product dossiers, evidence of bioequivalence, and compliance with Indian Pharmacopoeia standards.
Imported finished pharmaceutical formulations containing Ezetimibe are subject to quality testing by CDSCO-approved laboratories. Each batch must be accompanied by a Certificate of Analysis (CoA) issued by the manufacturer and a batch-wise certificate from the testing laboratory. Stability data demonstrating compliance with ICH Zone IV conditions is required. Upon arrival at Indian ports, customs drug inspectors conduct inspections to verify the authenticity of documents and samples. If a batch fails quality testing, it may be rejected, re-exported, or destroyed, depending on the severity of the non-compliance. Common quality issues identified in imports include deviations in dissolution profiles and impurity levels exceeding permissible limits.
Between 2024 and 2026, CDSCO has implemented stricter regulations for the import of pharmaceutical products, including mandatory import registration and licensing. The introduction of the Production Linked Incentive (PLI) scheme has incentivized domestic manufacturing, potentially affecting the volume of finished formulation imports. Bilateral agreements between India and South Africa have focused on mutual recognition of GMP standards, facilitating smoother trade in pharmaceutical products.
Market demand, customs duty structure, and competitive landscape ยท Import duty: 10%
India imports finished Ezetimibe formulations due to the demand for branded products, specific dosage forms not produced domestically, and the need to meet therapeutic requirements. The market size for Ezetimibe formulations in India is substantial, with a growing patient population requiring cholesterol-lowering medications. Domestic manufacturers may not fully meet the demand, leading to reliance on imports to bridge the gap.
The Basic Customs Duty (BCD) for HS Code 30049099 is 10%. An Integrated Goods and Services Tax (IGST) of 12% is applicable on imported goods. A Social Welfare Surcharge (SWS) of 10% is levied on the BCD. There are no exemptions or preferential rates for imports from South Africa. The total landed duty percentage is calculated by summing the BCD, SWS, and IGST, resulting in a cumulative duty burden on imported goods.
India sources finished Ezetimibe formulations from South Africa due to the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. South African suppliers offer formulations that may not be produced domestically, providing a competitive advantage in terms of product diversity and quality. Other suppliers include China, Germany, and the United States; however, South Africa's share in the Indian market is notable due to these factors.
Import rationale, competitive comparison, supply chain risk, and procurement strategy
India imports finished Ezetimibe formulations from South Africa due to the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. South African suppliers offer formulations that may not be produced domestically, providing a competitive advantage in terms of product diversity and quality.
Compared to other origins such as China, the European Union, and the United States, South Africa offers competitive pricing, adherence to international quality standards, and compliance with regulatory requirements. South African manufacturers are known for their reliability and consistency in product quality, making them a preferred choice for Indian importers.
Potential risks for Indian importers include reliance on a single source, currency fluctuations, regulatory changes, quality control issues, and shipping disruptions. To mitigate these risks, importers should diversify their supplier base, monitor currency exchange rates, stay updated on regulatory changes, conduct regular quality audits, and establish contingency plans for shipping disruptions.
Import license checklist, document requirements, quality testing, and compliance
SECTION:
Answers based on Indian Customs (DGFT) import records compiled by TransData Nexus
The top Ezetimibe suppliers from SOUTH AFRICA to India include RBC PHARMACEUTICALS PTY LTD, D.I. MEDICINE REGULATORY CONSULTANTS(D.I.PHARMACEU. The leading supplier is RBC PHARMACEUTICALS PTY LTD with import value of $248 USD across 1 shipments. India imported Ezetimibe worth $252 USD from SOUTH AFRICA in total across 2 shipments.
India imported Ezetimibe worth $252 USD from SOUTH AFRICA across 2 shipments. Data is from Indian Customs (DGFT) records. Values are in USD.
The main Indian buyers of Ezetimibe sourced from SOUTH AFRICA include MSN LABORATORIES PRIVATE LIMITED. The largest buyer is MSN LABORATORIES PRIVATE LIMITED with $252 in imports across 2 shipments.
The total value of Ezetimibe imports from SOUTH AFRICA to India is $252 USD, across 2 shipments and 2 foreign suppliers. Data source: Indian Customs (DGFT).
Data sourced from Indian Customs (DGFT) records. Verify regulatory and trade status with the agencies above.
Pharmaceutical Export-Import Analyst & Trade Intelligence Expert
Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.
linkedin.com/in/sureshsormareAll trade data is sourced from Indian Customs (DGFT) official shipping bill records โ the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
2 Verified Shipments
2 suppliers, 1 buyers tracked
Expert-Reviewed
By pharmaceutical trade specialists