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Home»Press Release»Veerhealth Care Successfully Completes USFDA Assessment of Form 4003 Pre-Inspection Records Request
Press Release

Veerhealth Care Successfully Completes USFDA Assessment of Form 4003 Pre-Inspection Records Request

Arjun SinghBy Arjun SinghDecember 16, 2024No Comments
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New Delhi [India], December 16: Veerhealth Care Ltd ((BSE: VEERHEALTH), AYUVEER, backed by Veerhealth Care’s expertise in Ayurveda, specializes in crafting ayurvedic medicines and oral care products with natural ingredients. With a focus on quality and affordability, Ayuveer aims to offer its customers an exceptional and safe daily care experience.

Veerhealth Care received a request from USFDA on 04/09/2024 about the submission of the required Documentation against FDA Form 4003.

Upon submission of the required documentation, USFDA issued FDA Form 4003a Records Receipt Confirmation, confirmed that there are no further requests at this time, and closed their RRA assessment.

The successful completion of the RRA assessment by the USFDA would enable the Company to open up its business in the US market. Veerhealth Care has already successfully manufactured and shipped Export orders worth approximately Rs. 3.50 Crores.

Also, the Company supplies to a leading Institutional Supplier in the United States of America and expects monthly orders worth Rs 1.50 Crores and annual orders worth Rs. 18 Crores, which can significantly boost the Total Revenues and PAT.

Recently, the Company had a factory visit from a leading corporate group from Russia, which is one of the largest suppliers of its exclusive brands and in-house brands in the following categories for more than 30 years: skin care, make-up cosmetics, household cleaning, baby diapers and pet foods. They are presented in all the biggest hyper and supermarkets like Gold Apple, L’Etoile, Rivegauche, and retail chains such as Metro Cash & Carry, Tander, Aushan, etc. This group is entering Oral Care market in Russia with advance formulations and has approved the plant for manufacturing and export of Oral Care products to the Russian market.

VeerHealth Care Limited (BSE – 511523) is involved in the business of manufacturing and supply of Ayurvedic medicines, oral care products & personal care products. All its finished formulations are manufactured in their own state-of-the-art manufacturing facility at Vapi, Gujarat designed to comply with international requirements with validated systems. The Company produces Intensive research based quality products with Expert guidance and enormous experience of renowned Vaidya of Mumbai, Dr. Vinod C. Mehta, an Ayurvedic Practitioner for 30 years and Dr. Rajiv Bhirud, an expert in formulations of cosmetic and personal care products. Some of its products are Health Care, Oral Care & Personal Care products like Shampoos, Conditioners, Lipbalm, Creams, Scrubs, Bath Salts, Shower Gels, Lotions, Ayurvedic Toothpaste & much more under Ayurvedic & Cosmetic License. Manufacturing Certifications: Ayurvedic Mfg. License, Ayurvedic GMP, Cosmetic Mfg. License, Cosmetic GMP, ISO 9001: 2015, Authorized Economic Operator T1 Certificate (Exporter) and Certification of Registration US FDA Labeler Code.

Commenting on the closure of assessment, Mr. Bhavin Shah – Managing Director of Veerhealth Care Limited, said, “I am delighted to share this achievement with shareholders. Successful completion of assessment by the USFDA against document submitted for the RRA, would enhance the company’s current standing and its reputation and visibility in the market. The Company is expected to get monthly repeat Export orders from clients of USA for its products in Oral Care category. It’s a testament to the quality of our products and services. We remain committed to delivering excellence and expanding our global footprint in the healthcare and

Personal care sector.”

  • The Company has upgraded its existing plant in Vapi, Gujarat to set up a bigger plant which is compliant with CGMP norms as required by the US FDA.
  • The company is expecting to reach Revenue of Rs. 100 crores with PAT of 10% in next 2 to 3 years.
  • Veerhealth Care Ltd. specializes in Manufacturing of Pure Vegetarian Toothpaste.

If you have any objection to this press release content, kindly contact pr.error.rectification@gmail.com to notify us. We will respond and rectify the situation in the next 24 hours.

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Arjun Singh
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