Silodosin API Manufacturers and Suppliers in India

Silodosin API
Silodosin is a selective alpha-1A adrenoceptor antagonist, formulated into capsules that relieve the urinary symptoms of benign prostatic hyperplasia (BPH). Bio-Synth manufactures silodosin API at its plant in Balanagar, Hyderabad. It is a white to off-white crystalline powder, very soluble in acetic acid and freely soluble in ethanol.

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Product Description

Product Description

Chemical name: (R)-1-(3-Hydroxypropyl)-5-(2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)indoline-7-carboxamide

CAS number: 160970-54-7

Molecular formula: C25H32F3N3O4

Molecular weight: 495.53 g/mol

Therapeutic category: Alpha-1A adrenoceptor antagonist (urology)

Form and colour: White to off-white crystalline powder

Solubility: Very soluble in acetic acid; freely soluble in ethanol; insoluble in water

Packing: As per requirement

Synonym: 2,3-Dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

Silodosin is a single enantiomer, the (R)-isomer. The (S)-isomer is an impurity to be controlled, not an alternative grade, so ask for the enantiomeric purity limit when you compare quotes.

Silodosin API Specification

Each batch ships with its Certificate of Analysis. Key specification limits:

Test

Limit

Total impurities

Not more than 1.0%

Any unspecified impurity

Not more than 0.1%

Loss on drying

Not more than 1.0% w/w

Residue on ignition

Not more than 0.1% w/w

Assay

Not less than 98.0% w/w and not more than 102.0% w/w

Silodosin has a monograph in the Japanese Pharmacopoeia, and Indian suppliers, including Bio-synth commonly offer either JP grade or an in-house (IH) specification. Reference-standard suppliers list several named silodosin impurities, including a dimer impurity and a carboxylic acid impurity, so ask which specified impurities are controlled individually and at what limit.

At 4 mg and 8 mg doses, particle size affects how evenly the capsule blend mixes and fills. A separate article on silodosin API in formulations covers what to specify.

Silodosin API Manufacturers in India

Silodosin is made at Bio-Synth’s Balanagar site in Hyderabad under drug manufacturing licence 118/HD/AP/96/B/R. The company has been making APIs since 1943, and Bio-Synth’s story traces that history.

The molecule joins three pieces: an indoline core carrying the 7-carboxamide and a 3-hydroxypropyl group on nitrogen, a chiral 2-aminopropyl linker, and a 2-(2,2,2-trifluoroethoxy)phenoxyethyl side chain. The stereocentre is set early, on the indoline intermediate, and must survive every later step intact. That makes chiral control a matter of the whole route, not just the final crystallisation. The reaction capabilities page lists the chemistry Bio-Synth runs in-house.

Bio-Synth makes the silodosin intermediates at Balanagar, including the chiral indoline, so the stereochemistry is under its control from the first chiral step onwards.

Silodosin API Suppliers in India

Silodosin is sold mainly as 4 mg and 8 mg capsules, and it also appears in combination products with dutasteride. For a capsule formulator, a useful enquiry covers four points:

  • Specification. JP, in-house or your own, including any particle-size requirement for your filling process.
  • Quantity. A trial lot for process development, then the commercial schedule.
  • Market. Where the finished capsules will be registered, so the document set can be matched.
  • Storage and transit. Check that your warehouse can hold the API at the storage condition on Bio-Synth’s specification, and say if the shipment needs temperature-controlled transport.

Every lot is dispatched with its batch CoA. The 60kL facility can produce 200kg/month of Silodosin.

Silodosin API Price in India

Bio-Synth quotes silodosin per order. What moves the price:

  • Grade. JP-grade material and a basic in-house specification are not priced alike.
  • Chiral and impurity limits. A tight (S)-isomer limit and individually specified impurities take more purification.
  • Particle size. Milling or micronising to a defined distribution adds a step.
  • Volume and documents. Commercial volumes price better than trial lots, and a regulated-market document set adds work.

Quality and Compliance

  • ISO 9001:2015. Bio-Synth’s management system is certified by DNV Business Assurance (UKAS-accredited), certificate 156792-2014-AQ-IND-UKAS, initially certified 20 August 2002, for “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”.
  • WHO-GMP. The site holds WHO-GMP certificate L.Dis.No. 150458/TS/2024, issued by the Drugs Control Administration, Government of Telangana, valid until 5 June 2027,for select products.
  • ICH Q7. Silodosin is manufactured in line with ICH Q7 principles for active pharmaceutical ingredients.
  • Release. Each batch is released by QC against its specification. Read more about Bio-Synth’s quality control systems.

How Silodosin Works and Where It Is Used

Alpha-1A adrenoceptors dominate in the smooth muscle of the prostate, bladder neck and prostatic urethra. Blocking them relaxes that muscle and eases urine flow. Silodosin is highly selective for this subtype: Tocris reports more than 55-fold selectivity for alpha-1A over alpha-1B and alpha-1D, and the alpha-1B receptors that control blood-vessel tone are largely spared.

Silodosin is prescribed for the signs and symptoms of BPH, such as a weak stream, frequent urination and a sense of incomplete emptying. It is sold as Rapaflo in the US and Urorec in Europe. More on its clinical and development use is in the article on what silodosin API is used for.

Silodosin API FAQs

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    Silodosin treats the urinary symptoms of benign prostatic hyperplasia (BPH), an enlarged prostate. It relaxes the smooth muscle of the prostate and bladder neck so urine flows more easily.

    The CAS number of silodosin is 160970-54-7. Its molecular formula is C25H32F3N3O4 and its molecular weight is 495.53 g/mol. The number 71675-85-9 belongs to amisulpride, not silodosin.
    Both are alpha-1 blockers used for BPH. Silodosin binds the alpha-1A subtype far more selectively than the alpha-1B and alpha-1D subtypes, while tamsulosin acts on both alpha-1A and alpha-1D receptors.
    Yes. Silodosin is the (R)-enantiomer. The (S)-enantiomer is treated as an impurity, so its limit is worth checking on any certificate of analysis.

    Bio-Synth supplies silodosin against a written specification with a batch Certificate of Analysis. State whether your registration references the Japanese Pharmacopoeia or an in-house specification, and the match will be confirmed before quoting.

    Every batch is dispatched with its Certificate of Analysis. Share where the finished capsules will be registered so the full document set can be agreed.

    Request a Quotation

    Send Bio-Synth your specification (JP, in-house or your own), any particle-size requirement, the trial and commercial quantities, and the market where the capsules will be registered. Use the contact page and the team will respond with a specification, a recent CoA and a quotation.

    Silodosin sits alongside carvedilol, rivaroxaban, bedaquiline and other generics in the Bio-Synth API portfolio.

    Bio-synth has almost 8 decades of experience manufacturing high quality APIs, including Silodosin API, making Bio-Synth one of the trusted manufacturers in India.

    Bio-synth is among the top Silodosin manufacturers in India, please reach out via the enquiry form with your requirements and we will get back to you at the earliest.

    Bio-Synth offers high-quality Silodosin API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures consistent and reliable Silodosin supply, making us a top choice for Silodosin API suppliers in India.

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

    To place an order for Silodosin API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific project needs.