Dydrogesterone

✅ Product Overview

Dydrogesterone is a synthetic progestogen (also known as a progestin), structurally and pharmacologically similar to natural progesterone. It is widely used in hormone replacement therapy and various gynecological disorders due to its excellent safety profile and targeted action.

We proudly manufacture Dydrogesterone at our state-of-the-art GMP-compliant facility, ensuring the highest standards of quality, safety, and efficacy.

• Manufacturing & Quality Standards

Our Dydrogesterone API is manufactured under the strictest quality control measures in line with:

• GMP (Good Manufacturing Practices)
• GLP (Good Laboratory Practices)
• Schedule M compliance as per the Drugs and Cosmetics Act, India

We maintain a clean, validated, and controlled environment for manufacturing, ensuring reproducibility and product consistency.

• Regulatory & Compliance

We ensure full regulatory compliance and provide the following documentation (on request):

• Certificate of Analysis (CoA)
• Drug Master File (DMF) / Technical Package
• GMP certificate
• GLP compliance documents
• Stability data
• Specifications as per IP / BP / In-house

• Analytical Standards & Testing

Dydrogesterone API is tested using validated methods according to the following specifications:

• Indian Pharmacopoeia (IP)
• British Pharmacopoeia (BP)
• In-house Specifications

Key testing includes:

• Identification (IR/UV)
• Assay (HPLC)
• Related substances
• Loss on drying
• Residual solvents (as per ICH guidelines)
• Heavy metals
• Microbial limits
• Particle size distribution

• Therapeutic Uses

Dydrogesterone is primarily used in the treatment of various gynecological and hormonal disorders, including:

1. Menstrual Disorders
• Dysmenorrhea (painful menstruation)
• Irregular menstrual cycles
• Amenorrhea (absence of menstruation)
2. Luteal Phase Support in Assisted Reproductive Technology (ART)
• IVF treatment
• Prevention of luteal phase deficiency
3. Endometriosis
• Reduces endometrial pain and growth
4. Premenstrual Syndrome (PMS)
• Mood swings, irritability, bloating
5. Threatened or Habitual Miscarriage
• Supports early pregnancy by stabilizing endometrium
6. Hormone Replacement Therapy (HRT)
• Used in combination with estrogen in postmenopausal women to reduce the risk of endometrial hyperplasia
7. Infertility Due to Luteal Insufficiency

• Packaging Information

Our API is supplied in high-quality packaging under controlled conditions to ensure product integrity.

• Standard packaging sizes: 1kg, 2,Kg, 5kg, 10kg (custom sizes on request)
• Packaging materials: HDPE drums, double LDPE
• Tamper-evident sealing
• Labeling: Includes batch number, manufacturing date, retest/expiry date, storage conditions

• Key Product Specifications (Typical)