Article -> Article Details

Introduction

Sacubitril‑Valsartan is an important combination drug (an angiotensin receptor–neprilysin inhibitor, ARNI) used to treat heart failure, particularly in patients with reduced ejection fraction. It merges two active molecules: sacubitril (a neprilysin inhibitor) and valsartan (an angiotensin receptor blocker). Because heart failure is an increasing health burden in India, there is growing demand for reliable access to this medicine.

Suppliers in India for this combination are responsible for active pharmaceutical ingredients (APIs), finished dosage forms (tablets), or both. They need to satisfy regulatory standards, ensure consistent quality, manage patents/IP, and compete on price.

Market Context & Demand

• Heart failure prevalence in India is estimated at about 1%, affecting about 8‑10 million individuals.
  
  

• The cardiology market in India is large; the ARNI segment (Sacubitril‑Valsartan) is growing rapidly. For example, recent estimates put the ARNI market at several hundred crores of INR, growing year over year at high double digits. 

• Price is a key concern, since cost of medicines is a barrier to access for many patients. Indian production of generics and lower‑cost formulations plays a big role.
  
  

Types of Suppliers in India

Suppliers can be categorized broadly as follows:

1. API manufacturers: These companies produce the raw chemicals—sacubitril, valsartan, or the combined API. They must meet standards like DMF filings (e.g. USDMF), good manufacturing practices (GMP), and often export to other countries.
   
   For instance, there are suppliers in India that offer Sacubitril/Valsartan API with regulatory filings in multiple countries.
   
   

2. Formulation / tablet manufacturers: These convert APIs into finished dosage forms (tablets), packaging, labelling, distribution. They may supply domestically, or act as exporters.
   
   

3. Wholesalers / distributors / trading houses: These act as intermediaries — sourcing from manufacturers, keeping stock, and supplying hospitals, pharmacies, tenders.
   
   

4. Tender / institutional suppliers: Supply via governmental or large‑scale procurement tenders. These often require more stringent quality checks, and sometimes price negotiations.
   
   

Regulatory, Patent & IP Concerns

• Patents / Exclusivity: Originally, the innovator company held IP rights over the ARNI combination (Entresto or similar brand names). Over time, generic manufacturers have entered many markets; in India, depending on patent expiry, licensing, and court/registry decisions, generic or branded generic versions are available.
  
  

• Regulatory approvals: Suppliers need to ensure compliance with regulatory bodies (Indian regulatory agencies, as well as foreign authorities if exporting). This includes Good Manufacturing Practices (GMP), stability data, safety/efficacy data, labelling, etc.
  
  

• Quality standards: APIs should have acceptable purity, stability, and consistency. Finished dosage forms must pass dissolution, bioavailability, and stability tests. Suppliers often need third‑party certifications (WHO‑GMP, ISO, etc.) and need to maintain documentation (e.g. DMF, master file for APIs) especially for export.
  
  

Examples & Pricing

• There are generic brands launched in India under different brand names with different strengths (e.g. combinations like 50 mg, 100 mg etc.). 

• Pricing is variable. As an example, a tablet in one strength was introduced at approx INR 19 for the lowest strength, INR 35 for mid strength, INR 45 for higher strength by one manufacturer.
  
  

• Suppliers also include smaller pharma companies that supply via trade‑platforms. For example, there are suppliers offering strips of Sacubitril + Valsartan under certain strengths via trade portals, with MOQ (minimum order quantities) and offers for bulk purchasers.

Challenges Faced by Suppliers

When dealing with Sacubitril‑Valsartan, suppliers in India face several challenges:

1. Patent / legal risk: Even if a patent has expired in one jurisdiction, in others it may still be valid. Also, licensed generics may need to avoid infringing formulations or data exclusivity.
   
   

2. Regulatory hurdles: Ensuring all approvals, safety and efficacy data, stability, compliance with GMP. For export, meeting standards of importing countries (e.g. US FDA, EMA, etc.).
   
   

3. Quality control: Ensuring consistency of raw material purity, avoiding contamination, maintaining shelf life, etc.
   
   

4. Supply chain & manufacturing costs: APIs may need specialized synthesis steps; any break in supply (raw materials, reagents) can disrupt production. Manufacturing equipment must meet high standards, and overheads (power, labour, infrastructure) matter.
   
   

5. Price competition: Many suppliers want to compete on cost, especially for domestic markets or tenders, which can squeeze margins.
   
   

6. Distribution & logistics: Ensuring cold chain if required, appropriate storage, handling, licensing for transportation, especially when distributing to remote areas.
   
   

7. Regulatory pricing and reimbursement: In India, government regulation of drug pricing (e.g. via National Pharmaceutical Pricing Authority) can influence what prices suppliers can charge, especially for essential medicines. Tender processes may demand low prices.
   
   

What to Look for in a Good Supplier

If you are someone seeking to procure Sacubitril‑Valsartan (for hospital, pharmacy, export, etc.), here are key criteria to evaluate:

• Regulatory certifications & approvals: GMP licence, DMF/CEF status, approvals from regulatory agencies relevant to your market.
  
  

• Quality of API and finished product: Certificates of analysis, batch‑to‑batch consistency, stability data, bio‑equivalence if applicable.
  
  

• Capacity & reliability: Ability to deliver required quantities on schedule; robust supply chain.
  
  

• Pricing transparency: Clear cost breakup, any licensing or IP costs, distribution/transport expenses.
  
  

• Legal safety: Ensure supplier is not infringing any patent or data exclusivity in your target market. Check that the brand/generic you procure is legally allowed there.
  
  

• Post‑sales support: Recall management, ability to handle returns, customer service, and handling adverse event reporting.
  
  

• Packaging & shelf‑life: Especially in tropical climates like much of India, packaging to resist humidity, heat, light; proper labeling; long enough shelf life.
  
  

Future Outlook

• As the population ages and incidence of heart failure rises (along with comorbidities like hypertension, diabetes), demand for effective treatments like Sacubitril‑Valsartan is likely to increase.
  
  

• More generic versions will enter the market; as patents expire, this could lead to increased competition and lower prices.
  
  

• There may be greater emphasis on local manufacturing of both APIs and formulations to reduce import dependency, control cost, and improve access.
  
  

• Regulatory harmonization (e.g. aligning with international norms) could make Indian suppliers more competitive for export.
  
  

• Innovation in formulations (e.g. improved delivery, fixed‑dose combinations, patient adherence) might become a differentiator.
  
  

Conclusion

India is already home to a number of suppliers of Sacubitril‑Valsartan—both at the API and finished product levels—serving domestic needs and increasingly reaching international markets. For procurers, the key is to ensure that suppliers meet robust quality, regulatory, and IP standards, while also being reliable and cost‑effective.

If you are considering partnering with or sourcing from a supplier, it makes sense to perform due diligence: check their licenses and certificates, sample product quality, verify legal status in your market, and assess their ability to supply consistently. With the right supplier, access to this important heart failure medicine can be broadened, helping many patients who need it.

URL: For more information, visit Bhasya International: Sacubitril Valsartan Supplier in India