Suppliers and packagers for generic pharmaceutical drug: RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-109-06	60 CAPSULE in 1 BOTTLE (27241-109-06)	2018-09-27
Ajanta Pharma Ltd	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-109-50	500 CAPSULE in 1 BOTTLE (27241-109-50)	2018-09-27
Ajanta Pharma Ltd	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-110-03	30 CAPSULE in 1 BOTTLE (27241-110-03)	2018-09-27
Ajanta Pharma Ltd	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	209859	ANDA	Ajanta Pharma USA Inc.	27241-110-10	100 CAPSULE in 1 BOTTLE (27241-110-10)	2018-09-27
Dr Reddys Labs Ltd	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	075742	ANDA	Dr. Reddy's Laboratories Limited	55111-129-05	500 CAPSULE in 1 BOTTLE (55111-129-05)	2001-01-12

Suppliers of Ranitidine Hydrochloride: A Comprehensive Analysis

Ranitidine hydrochloride, a histamine H2-receptor antagonist, has been widely used to treat gastrointestinal disorders such as peptic ulcers and gastroesophageal reflux disease (GERD). Despite its global recall in 2019 due to contamination with N-nitrosodimethylamine (NDMA), a probable carcinogen, the pharmaceutical industry continues to explore pathways for its safe reintroduction. This report examines the current landscape of ranitidine hydrochloride suppliers, regulatory challenges, market dynamics, and emerging trends shaping the availability of this API (active pharmaceutical ingredient) and finished formulations.

---

Global Regulatory Framework for Ranitidine Hydrochloride

Post-NDMA Contamination Scrutiny

The detection of NDMA in ranitidine products triggered widespread recalls and regulatory suspensions. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada mandated stringent testing protocols for NDMA levels in ranitidine batches[5][13]. These actions led to the temporary withdrawal of major brands like Zantac (Sanofi) and generic equivalents produced by companies such as Teva Pharmaceuticals and Dr. Reddy’s Laboratories[5][8]. Regulatory bodies now require manufacturers to demonstrate compliance with revised Good Manufacturing Practices (GMP) and stability testing to prevent NDMA formation during storage[8][13].

Certification and Compliance Requirements

Suppliers must obtain certifications such as the U.S. Drug Master File (USDMF), European Certificate of Suitability (CEP), and Japanese Drug Master File (JDMF) to validate API quality[1][9]. For instance, Solara Active Pharma Sciences regained its CEP in July 2021 after submitting data proving NDMA mitigation in its manufacturing process[8]. Similarly, Indian API manufacturers like Saraca Laboratories faced suspensions but have since implemented enhanced analytical controls[10]. These measures underscore the importance of regulatory alignment for suppliers aiming to re-enter the market[1][6].

---

Key Manufacturers and Suppliers of Ranitidine Hydrochloride

Active Pharmaceutical Ingredient (API) Suppliers

1. Dr. Reddy’s Laboratories (India): A leading global supplier of ranitidine hydrochloride API, Dr. Reddy’s adheres to USDMF and WHO-GMP standards. The company temporarily halted production post-NDMA recalls but has since invested in advanced purification technologies[1][10].
2. Saraca Laboratories Limited (India): Specializing in ranitidine hydrochloride Form I, Saraca supplies APIs to formulation giants like GlaxoSmithKline (GSK). Its EU-WC certification and focus on stability testing position it as a resilient player[6][10].
3. Solara Active Pharma Sciences (India): After addressing NDMA concerns, Solara regained regulatory approvals and now collaborates with Accord Healthcare to explore ranitidine’s reintroduction in Europe[8][10].
4. Manus Aktteva Biopharma LLP (India): This ISO 9001:2015-certified supplier offers ranitidine hydrochloride Form I with technical support for R&D and commercial-scale production[6].

Finished Formulation Suppliers

• J.B. Chemicals & Pharmaceuticals Ltd. (India): Markets Rantac, a ranitidine syrup and tablet brand available in 75 mg/5ml and 150 mg doses. The company emphasizes third-party manufacturing and PCD franchise opportunities[3][11].
• Ausmed Health Care (India): Supplies ranitidine oral solution IP at ₹80/box, targeting markets in Southeast Asia and Africa[3].
• Sanofi (France): Once the dominant supplier of Zantac, Sanofi halted over-the-counter sales but retains infrastructure for potential relaunch pending regulatory clearances[5][8].

---

Regional Supplier Dynamics

India: The API Manufacturing Hub

India accounts for over 60% of global ranitidine hydrochloride API production, with clusters in Hyderabad, Mumbai, and Bangalore. Companies like SMS Lifesciences and Neuland Laboratories leverage cost-effective synthesis routes and vertical integration to dominate exports[1][7][10]. However, the NDMA crisis impacted revenue streams, forcing suppliers to diversify into alternative H2 antagonists like famotidine[10].

China: Emerging Competitiveness

Chinese suppliers such as Xi'an Xinlu Biotechnology and Hubei Vanz Pharm offer ranitidine hydrochloride at competitive prices ($60–80/kg). Their focus on scaling production and obtaining WHO prequalification signals growing influence in Southeast Asian and African markets[12].

North America and Europe: Strategic Withdrawals

Major players like Pfizer and Boehringer Ingelheim have exited the ranitidine market, creating opportunities for generic suppliers. Accord Healthcare (UK) is evaluating API sources for a potential European relaunch, contingent on stability data and MHRA approvals[8][13].

---

Pricing and Market Access

API Price Volatility

Ranitidine hydrochloride API prices fluctuate based on raw material costs, regulatory compliance expenses, and geopolitical factors. Indian suppliers quote ₹895–₹1990/kg, while Chinese manufacturers offer lower rates at $60–80/kg[7][12]. Post-recall, prices surged by 30–40% due to supply chain disruptions, though stabilization is anticipated as production resumes[1][9].

Finished Product Pricing

In India, ranitidine formulations range from ₹79/box (100 ml syrup) to ₹120/box (150 mg tablets). Brands like Rantac (J.B. Chemicals) and Zinetac (GSK) maintain affordability, targeting price-sensitive markets[3][11]. Conversely, U.S. and European markets face premium pricing for NDMA-compliant products, with Zantac historically priced at $0.50–$1.50/tablet[5][13].

---

Challenges and Future Directions

NDMA Mitigation Strategies

Suppliers are adopting novel synthesis methods to minimize NDMA formation. Techniques include:

1. Low-temperature storage: Reducing thermal degradation of ranitidine.
2. Additive stabilization: Incorporating antioxidants like ascorbic acid.
3. Process optimization: Modifying reaction conditions to avoid nitrosamine precursors[8][10].

Legal and Reputational Risks

Over 2,400 lawsuits against ranitidine manufacturers as of April 2025 allege failure to warn consumers about NDMA risks[5]. While generic suppliers like Teva and Amneal benefit from liability protections, innovator companies face protracted litigation. This legal landscape necessitates robust risk management frameworks for suppliers[5][13].

Market Re-entry Prospects

Accord Healthcare’s exploratory efforts highlight cautious optimism. Successful reintroduction hinges on:

• Public trust restoration: Transparent communication about safety upgrades.
• Regulatory collaboration: Aligning with EMA and FDA on NDMA thresholds.
• Supply chain resilience: Securing multiple API sources to prevent shortages[8][10].

---

Key Takeaways

1. Regulatory compliance is non-negotiable for suppliers, with USDMF, CEP, and GMP certifications serving as market entry prerequisites.
2. Indian API manufacturers dominate global supply but face stiff competition from Chinese counterparts offering cost advantages.
3. NDMA mitigation remains a technical and reputational challenge, requiring continuous process innovation.
4. Legal liabilities from the Zantac lawsuit era continue to influence supplier strategies and market dynamics.

---

FAQs

1. Which companies are leading ranitidine hydrochloride API suppliers post-NDMA recalls?
Dr. Reddy’s Laboratories, Saraca Laboratories, and Solara Active Pharma Sciences are key players adhering to revised GMP standards[1][6][10].

2. How has the NDMA contamination affected ranitidine pricing?
API prices increased by 30–40% post-recall due to supply constraints and compliance costs, though stabilization is ongoing[1][9][12].

3. Are there efforts to reintroduce ranitidine in regulated markets?
Accord Healthcare (UK) is evaluating API sources for potential European relaunch, pending stability data and regulatory approvals[8][13].

4. What certifications do ranitidine suppliers require?
USDMF, CEP, JDMF, and WHO-GMP certifications are critical for accessing North American, European, and Asian markets[1][6][9].

5. How do Indian suppliers maintain cost competitiveness?
Vertical integration, economies of scale, and streamlined synthesis processes enable Indian manufacturers to offer APIs at ₹895–₹1990/kg[7][10].

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ranitidine-hydrochloride
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ranitidine-hydrochloride
3. https://dir.indiamart.com/impcat/ranitidine-hydrochloride.html
4. https://pharmaoffer.com/api-excipient-supplier/h2-antagonists/ranitidine
5. https://www.robertkinglawfirm.com/mass-torts/zantac-lawsuit/
6. https://www.manusaktteva.com/api/Ranitidine+hydrochloride+(Form+I)
7. https://www.tradeindia.com/manufacturers/ranitidine.html
8. https://pharmaceutical-journal.com/article/news/return-of-ranitidine-being-considered-by-uk-manufacturer
9. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ranitidine
10. https://www.moneycontrol.com/news/business/moneycontrol-research/ranitidine-controversy-nitrosamine-carcinogen-manufacturer-impact-4488351.html
11. https://www.medindia.net/drug-price/ranitidine.htm
12. https://www.made-in-china.com/products-search/hot-china-products/Ranitidine.html
13. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/recalls.html