IndiaMart
FIEO
BluepillExpress is a globally recognized pharmaceutical manufacturing and merchant export company based in India. We specialize in third-party manufacturing of high-quality pharmaceutical and nutraceutical products for regulated and semi-regulated markets. Our commitment to quality, regulatory compliance, and client confidentiality has made us a preferred contract manufacturing partner worldwide.
Among our extensive product offerings, Mifepristone + Misoprostol represents a significant component of our women’s health portfolio. This combination is widely used in medical termination of intrauterine pregnancy and is considered a critical component of reproductive healthcare.
Product Overview: Mifepristone + Misoprostol
Mifepristone is an antiprogestin that blocks the hormone progesterone, which is necessary for pregnancy to continue. Misoprostol is a prostaglandin analogue that induces uterine contractions to expel the pregnancy. The combination is used under medical supervision for the safe and effective termination of early pregnancies.
Indications:
- Medical termination of intrauterine pregnancy up to 70 days (10 weeks) of gestation.
- Cervical ripening before surgical abortion.
- Early miscarriage management (in selected clinical protocols).
Strengths and Combinations Available:
- Mifepristone 200 mg tablet + Misoprostol 200 mcg tablets (3 or 4 tablets, as per international guidelines).
- Custom packaging and strengths available upon client request and regulatory approval.
Why Choose BluepillExpress for Third-Party Manufacturing of Mifepristone + Misoprostol?
- WHO-GMP & ISO Certified Facilities:
Our state-of-the-art manufacturing plants comply with WHO-GMP, ISO 9001:2015, and Schedule M guidelines. We maintain sterile conditions, strict in-process quality checks, and end-product testing in every production batch. - Regulatory Support:
BluepillExpress offers comprehensive regulatory support, including:- Certificate of Analysis (CoA)
- Stability data
- Product dossiers (as per CTD or ACTD formats)
- Free Sale Certificate (FSC)
- Manufacturing License
- COPP (Certificate of Pharmaceutical Product)
- Customized Branding and Packaging:
We offer full customization of branding, artwork, and packaging according to the client’s country regulations and market preferences. Primary, secondary, and tertiary packaging can be developed in multiple languages. - Confidentiality and Compliance:
We understand the sensitive nature of Mifepristone + Misoprostol production and distribution. At BluepillExpress, client confidentiality and compliance with national and international abortion laws are strictly maintained.
Manufacturing Process and Quality Assurance
- Raw Material Procurement:
Active Pharmaceutical Ingredients (APIs) for Mifepristone and Misoprostol are sourced from certified vendors with full documentation including Drug Master Files (DMFs), GMP certifications, and COAs. Every batch of raw material undergoes stringent quality checks before acceptance. - Granulation and Blending:
Our formulation process begins with accurate weighing, granulation, and blending of active and excipient materials. For Misoprostol, special moisture-controlled handling procedures are followed to ensure product stability. - Compression and Coating:
Mifepristone tablets are compressed with optimal hardness and disintegration properties, followed by optional film coating. Misoprostol tablets are manufactured using advanced dry granulation or direct compression technologies depending on client specifications. - Packaging:
- Mifepristone: Blister or strip pack
- Misoprostol: Moisture-resistant Alu-Alu packaging
- Combo Kit: Customized mono-cartons containing both medications with patient information leaflets (PILs)
- In-Process and Finished Product Testing:
- Uniformity of content
- Tablet weight and hardness
- Dissolution profile
- Stability testing under ICH conditions
- Microbial load and endotoxin testing (especially for Misoprostol)
- Shelf Life and Storage Conditions:
Products are tested to ensure a shelf life of 18 to 24 months under appropriate packaging. Misoprostol is packed in desiccant-containing Alu-Alu packs to prevent moisture degradation.
Global Export and Documentation Support
BluepillExpress exports Mifepristone + Misoprostol kits to various countries across Asia, Africa, Latin America, and CIS regions. Each export shipment is supported by a full set of documents, including:
- Invoice and packing list
- Certificate of origin
- Bill of lading/airway bill
- COA, MSDS, and stability report
- Shipping conditions advisory
We also assist clients with product registration and import approvals in their respective countries.
Contract Manufacturing Process
At BluepillExpress, we simplify the third-party manufacturing journey for our clients:
- Initial Consultation:
Our technical and regulatory team reviews your market requirements, dosage forms, and regulatory constraints. - Product Customization:
We collaborate on formulation design, labeling, language preferences, and packaging aesthetics. - Documentation and Regulatory Preparation:
BluepillExpress provides full support for product registration and documentation filing. - Production and Quality Check:
Upon approval, production is initiated with full in-process quality checks and testing. - Dispatch and Logistics:
Products are delivered via air, sea, or courier service based on client preference, with real-time tracking and support.
Therapeutic Class and Market Demand
Mifepristone + Misoprostol belongs to the anti-progestin and prostaglandin analog therapeutic class. The combination is listed on the World Health Organization’s Model List of Essential Medicines due to its significance in reproductive health.
Market Growth Insights:
- Rising awareness of safe medical abortion
- Government and NGO initiatives promoting access to abortion care
- Increasing demand in low- and middle-income countries
- Shift towards private-label brands for medical abortion kits
BluepillExpress enables clients to leverage this growing demand by offering efficient third-party manufacturing solutions.
Key Features of BluepillExpress Mifepristone + Misoprostol Manufacturing
| Feature | Specification/Offering |
|---|---|
| Dosage Form | Oral Tablets (Film Coated/Uncoated) |
| API Source | GMP-Compliant, DMF Available |
| Packaging Options | Blister Pack, Alu-Alu, Kit Box with Leaflet |
| Shelf Life | 18–24 Months |
| Minimum Order Quantity (MOQ) | Flexible based on market needs |
| Certifications | WHO-GMP, ISO 9001:2015, FSSAI, COFEPRIS (select markets) |
| Export Capability | Asia, Africa, Latin America, CIS, MENA |
| Customization | Private Label, Artwork, Language, Regulatory Dossier Support |
Our Commitment to Women’s Health
At BluepillExpress, we recognize the importance of ensuring access to safe, effective, and affordable reproductive health solutions. Through the manufacturing of Mifepristone + Misoprostol, we contribute to global efforts in reducing maternal mortality and improving women’s health outcomes.
We are proud to partner with NGOs, hospitals, government agencies, and private brands to ensure that this essential medication reaches the women who need it most—safely and responsibly.
Partner With BluepillExpress
Whether you’re a pharmaceutical distributor, healthcare organization, or a startup brand looking to enter the women’s health market, BluepillExpress offers end-to-end solutions for the manufacturing and export of Mifepristone + Misoprostol.
Our Value Proposition:
- Transparent pricing and competitive manufacturing cost
- Flexible MOQ and delivery timelines
- Full regulatory and documentation support
- Ethical, compliant, and quality-focused production
