Verve Human Care Laboratories

Verve Human Care Laboratories, established in 2010, is a privately held pharmaceutical company headquartered in Dehradun, Uttarakhand, India. The company specializes in the development and manufacturing of finished pharmaceutical formulations, with a particular focus on controlled substances, including narcotics and psychotropic products. Their product portfolio encompasses a diverse range of dosage forms such as tablets, capsules, syrups, and injections.

As of March 31, 2016, Verve Human Care Laboratories reported an annual revenue of $9.25 million USD, with a net profit of $948,950 USD. The company is classified as a micro enterprise for the financial year 2023-24, indicating a workforce size of fewer than 10 employees. Their manufacturing facility is located in the pollution-free zone of Pharmacity Selaqui, Dehradun, and is designed to meet Good Manufacturing Practice (GMP) standards as specified by the World Health Organization (WHO).

Verve Human Care Laboratories operates a state-of-the-art manufacturing plant situated in Dehradun, Uttarakhand, India. The facility is designed to adhere to international standards, including WHO-GMP guidelines, ensuring the production of high-quality pharmaceutical products. The plant specializes in the production of oral pharmaceuticals, granules, and parenteral formulations, with a particular emphasis on controlled substances such as narcotics and psychotropic products.

Specific details regarding the CEO, CFO, and other key executives of Verve Human Care Laboratories are not publicly disclosed. However, the company has a dedicated team of professionals overseeing various departments, including operations, regulatory affairs, quality assurance, and international business. Notable personnel include:

• Sachin Mane – Senior General Manager Operations (Plant Head)
• Salamtullah Turk – Regulatory Affairs Manager
• Govind Singh Chauhan – QA Officer
• Priyanka Kushwaha – DRA Executive
• Smarika Rana – Quality Assurance Manager
• Rajesh Chhikara – Manager-DRA
• Shivam Verma – Director
• Yashwant Singh – Assistant General Manager
• Anupam Patel – Manager-International Business and Regulatory Affairs

Verve Human Care Laboratories has established a significant presence in various regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility holds approvals from several international regulatory bodies, such as WHO-GMP (India), FMHACA (Ethiopia), MCAZ (Zimbabwe), ZAMRA (Zambia), FDA (Ghana), TMDA (Tanzania), PPB (Kenya), and NDA (Uganda). These certifications indicate compliance with stringent manufacturing standards, facilitating access to these markets. While specific regulatory filings and approvals in the U.S., EU, UK, Australia, and Japan are not detailed, the company's adherence to international standards suggests a strategic approach to market access in these regions.

Verve Human Care Laboratories has expanded its reach into emerging markets across Africa, Latin America, Southeast Asia, and the Middle East. The company's product portfolio includes a wide spectrum of narcotics and psychotropics, such as Morphine, Fentanyl, Pethidine, Oxycodone, Codeine, Diazepam, Ketamine, Ephedrine, and Phenobarbital, available in various dosage forms including injections, tablets, and transdermal systems. The facility's compliance with WHO-GMP standards and approvals from regulatory bodies in countries like Ethiopia, Ghana, Kenya, and Uganda enhance its ability to supply high-quality pharmaceuticals to these regions.

Verve Human Care Laboratories demonstrates a diversified geographic strategy by exporting its products to multiple regions, including Africa, Latin America, Southeast Asia, and the Middle East. This approach mitigates concentration risk and leverages growth opportunities in emerging markets. The company's adherence to international manufacturing standards and possession of various regulatory approvals underscore its commitment to quality and compliance, supporting its strategic direction in global market expansion.

Specific details regarding Verve Human Care Laboratories' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. However, the company's manufacturing facility is designed to meet international standards, including those specified by the WHO, indicating a commitment to quality and regulatory compliance.

Verve Human Care Laboratories' manufacturing facility holds WHO-GMP certification, ensuring compliance with international manufacturing standards. While specific EU GMP certificates and European Directorate for the Quality of Medicines & HealthCare (EDQM) status are not detailed, the company's adherence to WHO-GMP guidelines suggests a commitment to quality that aligns with EU standards.

Verve Human Care Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India, indicating compliance with national regulatory requirements. The company's manufacturing facility is located in Dehradun, Uttarakhand, and is designed to meet WHO-GMP standards, reflecting adherence to both national and international manufacturing practices.

Specific details regarding Form 483 observations, warning letters, or import alerts issued to Verve Human Care Laboratories are not publicly available. The company's adherence to international manufacturing standards and possession of various regulatory approvals suggest a proactive approach to compliance and quality assurance.

Verve Human Care Laboratories operates in a competitive market, facing competition from established players such as Unither, Akums, Jubilant Life Sciences, Recipharm, and CoreRx. The company's focus on controlled substances, including narcotics and psychotropic products, differentiates it from competitors. While specific market share comparisons are not available, the company's adherence to international manufacturing standards and possession of various regulatory approvals position it as a competent player in the pharmaceutical manufacturing sector.

Verve Human Care Laboratories' specialization in controlled substances, including narcotics and psychotropic products, sets it apart from competitors. The company's diverse product portfolio, encompassing sterile dosage forms, transdermal drug delivery systems, oral dissolving films, and oral solid dosage forms, demonstrates its commitment to innovation and quality. Adherence to international manufacturing standards and possession of various regulatory approvals further enhance its competitive advantages.

Verve Human Care Laboratories' strategic direction focuses on the manufacturing and export of pharmaceutical finished formulations, with a particular emphasis on controlled substances. The company's adherence to international manufacturing standards and possession of various regulatory approvals underscore its commitment to quality and compliance. The diverse product portfolio and expansion into emerging markets reflect a proactive approach to growth and market diversification. Future outlooks may include further expansion into new markets and the development of additional product lines to meet global healthcare needs.

Verve Human Care Laboratories has demonstrated a consistent track record in manufacturing and exporting pharmaceutical products, with a total export value of $945,000 USD across 60 shipments. The company's product portfolio includes analgesics, CNS & psychiatric medications, and cardiovascular drugs, with a concentration in the analgesics & antipyretics category. The top five products—Morphine, Diazepam, Fentanyl, Digoxin, and Clobazam—account for 100% of the company's export value, indicating a focused product strategy. The company's adherence to international manufacturing standards and possession of various regulatory approvals suggest reliability and commitment to quality.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• FDA Approval: Confirm the company's FDA facility registrations and approved ANDAs through the FDA's official website.

• WHO-GMP Certification: Verify the WHO-GMP certification status via the WHO's official website.

• EU GMP Certification: Check the EU GMP certification status through the European Medicines Agency (EMA) website.

• ISO Certification: Request ISO certification details from the company and verify through the International Organization for Standardization (ISO) website.