Sterovance Biotech – North America Market

“Quality Hormone APIs, Delivered Across North America.”

Sterovance Biotech, a specialized pharmaceutical division of Zoesoe Exports Private Limited, is engaged in the sourcing, marketing, and export of high-quality steroid and hormone Active Pharmaceutical Ingredients (APIs) across North American pharmaceutical markets.

With strong expertise in highly regulated markets, we supply APIs compliant with US FDA, Health Canada, cGMP, and ICH guidelines, ensuring seamless regulatory acceptance for ANDA, NDA, and NDS/ANDS pathways.

North America is one of the most advanced and strictly regulated pharmaceutical regions globally, requiring full compliance, data integrity, and validated manufacturing processes.

Our Presence Across North America

Sterovance Biotech supports API supply across key markets including:

• United States

• Canada

• Mexico

We understand region-specific regulatory frameworks including US FDA, Health Canada, and COFEPRIS requirements, ensuring efficient and compliant API supply.

Manufacturing & Supply Advantage

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

• Compliance with US FDA, Health Canada, and ICH guidelines

• Strict adherence to cGMP and data integrity requirements

• High purity and consistent batch quality

• Competitive pricing for premium markets

• Reliable and scalable supply chain

Regulatory & Documentation Support (North America-Focused)

We provide comprehensive documentation aligned with North American regulatory requirements:

• DMF (Drug Master File) – US FDA compliant

• LOA (Letter of Authorization)

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability Data (ICH guidelines)

• Impurity Profile & Residual Solvent Data

• Validation Data (Process & Analytical)

• GMP Certificates

• Support for ANDA / NDA (USA) and NDS / ANDS (Canada) submissions

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 (North America Orders)

1. Send Inquiry
   API Name | Quantity | Target Country

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

3. Quotation
   Competitive pricing | Availability | Delivery timeline

4. Documentation Support
   DMF LOA | Regulatory documentation | Submission support

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

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

7. Delivery & Support
   Full documentation | Regulatory compliance support

Why Choose Sterovance Biotech for North America

• Strong expertise in US FDA, Health Canada, and COFEPRIS regulations

• DMF-backed APIs with LOA support

• cGMP-compliant manufacturing facilities

• Experience in highly regulated markets

• High-quality documentation and validation support

• Reliable and scalable supply chain

• Competitive pricing with global standards

• Transparent and ethical business practices

Your Trusted API Partner Across North America

Sterovance Biotech is committed to supporting the pharmaceutical industry across North America by delivering high-quality steroid and hormone APIs with strict regulatory compliance, robust documentation, and reliable global supply.

Hashtags (North America Market Focus)

#SterovanceBiotech #ZoesoeExports #NorthAmericaPharma #USFDA #HealthCanada #COFEPRIS #PharmaceuticalAPI #HormoneAPI #SteroidAPI #APIExport #ANDA #NDA #DMF #LOA #cGMP #RegulatoryCompliance #PharmaLogistics #BulkAPI #GlobalPharma