CORONA Remedies secures EU-GMP certification for hormone facility, renews approval for Ahmedabad OSD plant

CORONA Remedies has received European Union Good Manufacturing Practice (EU-GMP) Compliance Certification for its hormone manufacturing facility and renewed EU-GMP approval for its Oral Solid Dosage (OSD) manufacturing facility at Bhayla, Ahmedabad.

According to the company, the approvals strengthen its manufacturing and quality systems and support its plans in hormone therapies and women’s healthcare.

The EU-GMP certifications cover compliance certification for the company’s hormone manufacturing facility and the renewal of EU-GMP approval for its General Oral Solid Dosage facility in Ahmedabad (Bhayla).

The Oral Solid Dosage facility has manufacturing capabilities for tablets, capsules, softules, powders and semi-solid formulations such as gels. The certification also covers primary packaging of Oral Solid Dosage products, including hormone-containing formulations.

CORONA Remedies stated that the accreditation reflects its quality and compliance systems and manufacturing framework.

With the accreditation, the company plans to expand its presence in hormone therapies and reproductive healthcare products, including progestin-based therapies and Hormone Replacement Therapy (HRT) products.

These therapies are primarily used for menstrual regulation, hormonal deficiency management and post-menopausal syndrome management.

The company also intends to utilise these manufacturing capabilities across its core therapeutic segments, including urology, cardiology and endocrinology.

According to CORONA Remedies, the approvals validate its capability to manufacture hormone products that meet international quality standards and are expected to create opportunities through partnership models across Europe, LATAM, APAC and Rest of the World (ROW) markets.

The company highlighted that Europe represents a significant market for hormone and reproductive healthcare therapies, with approximately 159.3 million women of reproductive age between 15 and 49 years across the region.

It further noted that the European female hormone market is projected to exceed approximately USD 8.24 billion by 2030. Growth is being driven by awareness around hormonal health, prevalence of hormonal disorders, an ageing population, and adoption of Hormone Replacement Therapies (HRT).

Commenting on the development, Viral Sitwala, Executive Director, CORONA Remedies Limited, said, “We view this accreditation as a reflection of our unwavering commitment to quality and our philosophy of “One World. One Quality.” By adopting uniform global practices, we aim to serve both the Indian market and other regulated/semi-regulated markets from this facility.

Backed by strong scientific expertise, rapidly expanding manufacturing capabilities, and a clear strategic vision, we remain committed to advancing accessible, high-quality healthcare in India while taking our Hormone portfolio to global markets — driven by our belief: “THINK HORMONE… THINK CORONA.”

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