Sterovance Biotech – United States Market

“Quality Hormone APIs, Delivered to the United States.”

Sterovance Biotech, a specialized pharmaceutical division of Zoesoe Exports Private Limited, is dedicated to the sourcing, marketing, and export of high-quality steroid and hormone Active Pharmaceutical Ingredients (APIs) to the United States pharmaceutical market.

With a deep understanding of the stringent regulatory framework governed by the U.S. Food and Drug Administration, Sterovance Biotech supplies APIs that comply with US FDA, cGMP, and ICH guidelines, ensuring full regulatory compliance for ANDA and NDA submissions.

The United States is the largest and most strictly regulated pharmaceutical market in the world, requiring complete transparency, quality assurance, and documentation compliance.

Our Presence in the United States

Sterovance Biotech supports pharmaceutical supply across major regions including New York City, Los Angeles, Chicago, and Houston.

We understand US import procedures, FDA compliance, and regulatory submission pathways, ensuring smooth and compliant API supply.

Manufacturing & Supply Advantage

All APIs are sourced from US FDA-compliant and cGMP-certified manufacturing facilities in India, ensuring:

• Compliance with US FDA and ICH guidelines

• Strict adherence to cGMP requirements

• Complete batch traceability and data integrity

• Competitive pricing for US market

• Reliable and scalable supply chain

Sterovance Biotech operates through multiple GMP-compliant manufacturing sites, ensuring regulatory readiness and uninterrupted supply.

Regulatory & Documentation Support (USA-Focused)

We provide comprehensive documentation aligned with US regulatory requirements:

• DMF (Drug Master File) – US FDA compliant

• LOA (Letter of Authorization) for DMF reference

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability Data (ICH guidelines)

• Impurity Profile & Residual Solvent Data

• Validation Data (Process & Analytical)

• GMP Certificates

• Complete support for ANDA/NDA submission

Our Product Portfolio

Testosterone & Esters

Testosterone — USP | Testosterone Propionate — USP | Testosterone Enanthate — USP | Testosterone Cypionate — USP | Testosterone Undecanoate — IH | Testosterone Decanoate — IH

Nandrolone

Nandrolone (Base) | Nandrolone Decanoate — USP | Nandrolone Phenylpropionate — IH

Boldenone

Boldenone — IH | Boldenone Undecylenate — IH

Methenolone

Methenolone Acetate — IH | Methenolone Enanthate — IH

Oxandrolone

Oxandrolone — USP

Estrogens & Esters

Estradiol — USP | Estradiol Valerate — USP | Estradiol Cypionate — USP | Ethinyl Estradiol — USP

Progesterone & Derivatives

Progesterone — USP | Hydroxyprogesterone Caproate — USP | Medroxyprogesterone Acetate — USP | Dydrogesterone — IH | Norethisterone — USP

Thyroid Hormone

Levothyroxine Sodium — USP

Insulin APIs (Biological Hormones)

Insulin Human (Recombinant) — USP

Our Working Process (USA Orders)

1. Send Inquiry
   API Name | Required Quantity | US Market Requirement

2. Technical Evaluation
   DMF availability | Regulatory feasibility | Compliance check

3. Quotation & Pricing
   Competitive pricing | Availability | Delivery timeline

4. Documentation Support
   DMF LOA | Regulatory documents | Submission assistance

5. Order Processing
   cGMP manufacturing | QA/QC compliance | Data integrity

6. Shipping & Logistics
   Air Freight (preferred for USA)
   Temperature-controlled shipments (if required)

7. Delivery & Regulatory Support
   Full documentation | FDA compliance support | Ongoing assistance

Why Choose Sterovance Biotech for the United States

• Strong expertise in US FDA regulatory requirements

• DMF-backed APIs with LOA support

• cGMP-compliant manufacturing facilities

• Experience in ANDA/NDA regulated markets

• High-quality documentation and validation support

• Reliable and scalable supply chain

• Competitive pricing for global standards

• Transparent and ethical business practices

Your Trusted API Partner for the United States

Sterovance Biotech is committed to supporting the pharmaceutical industry in the United States by delivering high-quality steroid and hormone APIs with full US FDA compliance, robust documentation, and reliable global supply.

Hashtags (USA Market Focus)

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