Clomiphene Citrate structure
Human APIs

Clomiphene Citrate

CAS Registry Number: 50-41-9

Clomiphene Citrate is a selective estrogen receptor modulator (SERM) used as first-line ovulation induction agent in anovulatory infertility (typically PCOS-associated). Manufactured to USP and Ph. Eur. monograph specifications as the racem

Product information

Clomiphene Citrate is a selective estrogen receptor modulator (SERM) used as first-line ovulation induction agent in anovulatory infertility (typically PCOS-associated). Manufactured to USP and Ph. Eur. monograph specifications as the racemic mixture of enclomiphene and zuclomiphene isomers, with full stereochemical documentation and impurity profile per ICH Q3A.

Product specifications

CAS Registry Number
50-41-9
Therapeutic Category
Human APIs
API Technology
Synthetic / Semi-synthetic (per molecule)
Development Status
Commercial — stocked
Manufacturer
Longshine Boi-Tech Pvt. Ltd.
Facility
Pune, Maharashtra, India 411001

Regulatory filings & documentation

We maintain regulatory dossiers in the following jurisdictions for Clomiphene Citrate-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.

US FDA DMF (Type II)
EDQM CEP (where applicable)
Brazil ANVISA
Canada Health Canada
Japan PMDA
Korea MFDS
GCC SFDA
EU CEP
WHO-GMP & ISO 9001:2015 certified. US FDA Drug Master File available. EDQM CEP supplied for EU procurement. Pharmacopoeial release against USP, Ph. Eur., IP, JP. CoA on every batch. First-shipment lead time 7-10 business days for stocked APIs.
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Frequently asked questions about Clomiphene Citrate

What is Clomiphene Citrate used for?

Clomiphene Citrate is supplied as a pharmaceutical-grade human apis for use by regulated pharmaceutical manufacturers, contract development and manufacturing organisations (CDMOs), and research institutions. Buyers using Clomiphene Citrate typically reference it under CAS Registry Number 50-41-9.

What quality and regulatory standards does Longshine Boi-Tech's Clomiphene Citrate meet?

Our Clomiphene Citrate is manufactured under WHO-GMP and ISO 9001:2015 conditions in Pune, India. Per-batch Certificate of Analysis (CoA) is released against USP / Ph. Eur. / IP / JP specifications depending on destination market. We hold US FDA Drug Master File and EDQM Certificate of Suitability dossiers for the molecules where regulatory recognition is required; Letter of Authorization (LoA) is issued at no charge to qualified buyers.

How do I request a quote, sample, or proforma invoice for Clomiphene Citrate?

Quote requests for Clomiphene Citrate are turned around within 24 business hours (IST, Pune). Bulk APIs typically ship within 7-10 business days of confirmed PO; air freight to North America and Europe runs 4-5 days door-to-door. Sample agreements are signed before shipping QC-grade material to your formulation laboratory.

Which countries does Longshine Boi-Tech supply Clomiphene Citrate to?

We export Clomiphene Citrate to 50+ countries including the United States, Canada, Mexico, Brazil, the European Union, the United Kingdom, Japan, Australia, South Korea, the GCC and across South-East Asia. All regulatory documents (DMF / CEP / LoA) and shipping incoterms (EXW, FCA, CIP, DAP, DDP) are negotiated per buyer.

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Related categories & resources

Browse the full Human APIs catalogue or all 560+ products. Reference documents: certifications portfolio · quality system · FDA DMF buyer guide · EU CEP supplier guide · complete product index.