Testosterone Cypionate API Exporter from Bangalore, India | Global Supply

Testosterone Cypionate API Exporter from Bangalore, India | WHO GMP Certified | Aarise Pharmaceuticals

Aarise Pharmaceuticals is a WHO GMP certified Testosterone Cypionate API manufacturer and exporter based in India, serving formulation companies, distributors, and pharmaceutical exporters in Bangalore and internationally. We supply USP/BP grade Testosterone Cypionate API at 99%+ HPLC purity with complete batch documentation — COA, MSDS, Certificate of Origin, and regulatory support for 18+ export markets. As one of India’s established Testosterone Cypionate API suppliers, Bangalore-based pharma companies rely on us for fast, reliable supply and export-ready documentation.

About Testosterone Cypionate API

Testosterone Cypionate is one of the most widely prescribed testosterone ester APIs globally, used primarily in injectable formulations for testosterone replacement therapy (TRT) and hypogonadism treatment. The cypionate ester gives Testosterone Cypionate a long half-life of approximately 8 days, enabling weekly or biweekly injection schedules — making it the preferred testosterone formulation in the US market and increasingly popular across Latin America, the Middle East, and Southeast Asia.

Key data on Testosterone Cypionate API:

• IUPAC Name: [(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] 3-cyclopentylpropanoate
• CAS Number: 58-20-8
• Molecular Formula: C₂₇H₄₀O₃
• Molecular Weight: 412.60 g/mol
• Pharmacopoeial Standard: USP / BP
• Ester: Cyclopentylpropionate (cypionate)
• Half-life (injectable oil): ~8 days (estimated)

Primary uses of Testosterone Cypionate API:

• Testosterone Replacement Therapy (TRT) oil-in-sesame/cottonseed oil injectables (100mg/mL, 200mg/mL)
• Hypogonadism treatment — primary and secondary hypogonadism
• Gender-affirming hormone therapy (GAHT) formulations
• Delayed puberty treatment (short-course injectable formulations)
• Androgen deficiency in males — injectable depot formulations

Testosterone Cypionate API Specifications

• Appearance: White or off-white crystalline powder
• Grade: USP / BP
• Purity (HPLC): 99.0%+
• CAS Number: 58-20-8
• Specific Rotation: +85° to +92° (in dioxan)
• Melting Point: 100–102°C
• Water Content (Karl Fischer): NMT 0.5%
• Related Substances: Total NMT 1.0%
• Residual Solvents: Meets ICH Q3C Class 2 limits
• Heavy Metals: Meets pharmacopoeial limits
• Microbial Limits: Meets USP/BP limits
• Shelf Life: 36 months from date of manufacture
• Storage: Below 25°C, dry place, protected from light

Why Bangalore Companies Choose Aarise for Testosterone Cypionate API

Bangalore’s pharmaceutical sector — centred around Electronic City, Peenya Industrial Area, and Whitefield — includes established formulation companies and pharma exporters who need API suppliers with regulatory-grade quality. Our Testosterone Cypionate API is specifically suited to Bangalore manufacturers targeting the US, Latin American, and Middle Eastern markets for TRT formulations:

• USFDA DMF Available: Drug Master File filed with USFDA for Testosterone Cypionate API. Letters of access available for Bangalore companies filing ANDAs for US market entry.
• WHO GMP Manufacturing: Our Haridwar facility is WHO GMP certified — accepted by regulators in the US, EU, and across our 18+ export market countries.
• High Demand Export Market: Testosterone Cypionate is the most prescribed testosterone ester in the US — significant opportunity for Bangalore manufacturers targeting USFDA-approved generic TRT formulations.
• Fast Delivery: Air courier delivery to Bangalore in 24–48 hours. Surface freight 3–4 days.
• Competitive Pricing: Direct manufacturer pricing with no intermediary markups. Volume discounts from 5kg+.

Quality and Manufacturing Standards

Our Testosterone Cypionate API is manufactured under WHO GMP conditions with full pharmacopoeial compliance verification:

• Synthesis: Chemical synthesis from registered starting materials. Full audit trail maintained from starting material to finished API.
• Purification: Recrystallisation and chromatographic purification to achieve 99%+ purity
• Analytical Testing: HPLC assay, related substances (HPLC), specific rotation (polarimeter), water content (Karl Fischer), residual solvents (GC-HS), microbial limits
• Reference Standards: USP and BP reference standards used for all HPLC assay and related substance testing
• Batch Records: Full manufacturing batch records maintained per WHO GMP requirements
• QA Release: QA-approved batch release — no batch ships without QA sign-off on the COA

Documentation Package for Bangalore Export Manufacturers

Bangalore-based companies manufacturing TRT injectables for export to the US, Latin America, or Middle East need comprehensive API documentation. We provide:

• Certificate of Analysis (COA): Full batch-specific COA with all test results and QA sign-off
• MSDS (Material Safety Data Sheet): 16-section GHS-compliant MSDS
• Certificate of Origin: India-origin certificate for customs and regulatory purposes
• USFDA DMF: Filed DMF for ANDA support — letters of access on request
• WHO CPP (Certificate of Pharmaceutical Product): Available for export market regulatory submissions
• Pharmacopoeial Compliance Statement: Written confirmation of USP/BP compliance
• Stability Data: Real-time and accelerated stability data per ICH Q1A(R2) available on request
• Regulatory Dossier Support: Technical documentation support for ANDA, CEP, and country-specific regulatory filings

Packaging and Delivery to Bangalore

Packaging sizes available for Bangalore clients:

• 100g (sample/trial orders)
• 500g
• 1kg
• 5kg
• 10kg
• 25kg (bulk commercial orders)
• Custom quantities on request

All quantities are packaged in double-layered aluminium foil bags inside HDPE containers or fibre drums. Labels include batch number, manufacture date, expiry date, storage conditions, and pharmacopoeial grade. Delivery to Bangalore: air courier 24–48 hours; road freight 3–4 business days from Haridwar.

Minimum Order Quantities and Pricing

• Sample Orders: 100g minimum. Full COA and MSDS included. Sample cost adjusted against first commercial order.
• Commercial Orders: 1kg minimum. Competitive ex-works pricing. Quote within 4 business hours.
• Bulk Pricing: Volume discounts from 5kg. Annual supply agreements with committed pricing available.

Frequently Asked Questions — Testosterone Cypionate API from Bangalore

What grade of Testosterone Cypionate API do you supply?

We supply Testosterone Cypionate API in USP and BP grades. Purity is 99.0%+ (HPLC) for both grades. The COA specifies which pharmacopoeial standard was used for batch testing. EP-grade batches are available on request with supplementary testing to European Pharmacopoeia monograph specifications.

Do you have a USFDA Drug Master File (DMF) for Testosterone Cypionate?

Yes. We have a filed USFDA Drug Master File (DMF) for Testosterone Cypionate API. Letters of access can be provided to Bangalore-based ANDA filers for referencing the DMF in regulatory submissions for the US market. Please contact our regulatory affairs team with your ANDA application details to initiate the letter of access process.

What is the minimum order for Testosterone Cypionate API for Bangalore delivery?

Minimum order is 100g for sample/trial orders and 1kg for standard commercial orders. Bulk pricing applies from 5kg. We can accommodate orders from 100g to 25kg with standard lead times of 3–7 business days from confirmed order.

What documentation do you provide for Testosterone Cypionate API export from Bangalore?

We provide the complete documentation package: COA (batch-specific, QA-approved), MSDS, Certificate of Origin, WHO CPP, USFDA DMF letter of access, pharmacopoeial compliance statement, and stability data. For Bangalore companies exporting to regulated markets, we also provide technical dossier support for ANDA, CEP, and country-specific registration filings.

How do I get a price quote for Testosterone Cypionate API for delivery to Bangalore?

Email [email protected] with the grade (USP/BP), quantity required, and whether you need DMF letter of access. Our team responds within 4 business hours with pricing, current COA, and lead time. Samples can be dispatched to Bangalore within 24–48 hours of order confirmation.

Can you supply Testosterone Cypionate API for TRT injectable manufacturing?

Yes. Testosterone Cypionate API is our highest-volume steroid API, supplied to multiple Bangalore and pan-India manufacturers producing oil-based injectable TRT formulations. We have direct experience supplying for US market ANDA products and can provide the regulatory documentation and quality consistency required for injectable-grade manufacturing. Contact us to discuss your specific formulation requirements.

Why Aarise Pharmaceuticals is Bangalore’s Preferred Testosterone Cypionate API Supplier

• WHO GMP Certified: Manufacturing standards accepted by CDSCO and international regulators including USFDA
• USP/BP Grade Compliance: Full pharmacopoeial testing with reference standards on every batch
• 99%+ HPLC Purity: Consistently high purity — batch-specific HPLC chromatogram on COA
• USFDA DMF Available: Critical for Bangalore companies targeting US ANDA approval
• Export Experience: Proven track record supplying Testosterone Cypionate API to manufacturers in 18+ countries
• Fast Bangalore Delivery: 24–48 hour air courier; 3–4 day surface freight
• Competitive Pricing: Direct manufacturer pricing — no intermediary margins
• Dedicated Account Management: Named account manager for Bangalore accounts — fast quotations and priority dispatch