Organosyn Life Sciences Private Limited

Organosyn Life Sciences Private Limited is a pharmaceutical company established on August 11, 2011, in Hyderabad, Telangana, India. The company is registered under the Corporate Identification Number (CIN) U24100TG2011PTC150729. It operates as a private limited company with an authorized capital of ₹20.00 crore and a paid-up capital of ₹9.70 crore. The registered office is located at Hno 3-1-2 Plot No 17 Motivalley Goyal Colony Tirumalgherry Hyderabad 500015, Hyderabad, Telangana, 500015.

The company's primary focus is on the manufacture and marketing of high-quality generic pharmaceutical formulations. It specializes in solid oral dosage forms, including tablets, capsules, and dry powders in bottles and sachets. Additionally, Organosyn Life Sciences has a dedicated hormonal facility for tablets and capsules. The manufacturing plants have an annual capacity of approximately 2 billion units and are approved by various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine.

Organosyn Life Sciences Private Limited operates a manufacturing unit through its joint venture with GIL Agrotech (India) Pvt. Ltd., known as Evertogen Lifesciences Ltd. Evertogen specializes in the production of solid oral dosage forms, such as tablets, capsules, and dry powders in bottles and sachets. The facility also includes a dedicated hormonal production area for tablets and capsules. With an annual capacity of approximately 2 billion units, the plant is equipped with modernized equipment and has received approvals from regulatory agencies like the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine.

The leadership team of Organosyn Life Sciences Private Limited includes:

• Manav Jassal: Director since December 29, 2012.

• Sat Paul Jassal: Director since June 8, 2016.

The company has also had past directors, including Arun Prakash, Raminder Kaur, and Roopal Jain.

Organosyn Life Sciences Private Limited has made significant strides in regulated markets, particularly in the United States, European Union, United Kingdom, Australia, and Japan. The manufacturing facility, Evertogen Lifesciences Ltd., has obtained approvals from several regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine. These approvals indicate the company's commitment to meeting international quality standards. However, specific details regarding regulatory filings, approvals, and market access status in the U.S., EU, UK, Australia, and Japan are not readily available in the provided sources.

Organosyn Life Sciences Private Limited has expanded its presence in emerging markets, notably in Africa, Latin America, and Southeast Asia. The company acquired the branded formulation business from Synmedic Ltd. in 2011, a company established in Ukraine since 1996, which has a wide range of products in different therapeutic segments. This acquisition has enabled Organosyn to establish a marketing base in Ukraine and Central Asia. The company has marketing offices in Ukraine and Kazakhstan and is involved in the promotion and marketing of branded formulations through its team of highly motivated and trained professionals.

Organosyn Life Sciences Private Limited has adopted a strategic approach to geographic diversification by expanding its operations into emerging markets such as Ukraine and Kazakhstan. The acquisition of Synmedic Ltd.'s branded formulation business in 2011 facilitated this expansion, allowing the company to establish a marketing base in Ukraine and Central Asia. The marketing offices in Ukraine and Kazakhstan, along with dedicated teams, indicate a focused effort to penetrate these regions. However, specific details regarding the company's presence in Africa, Latin America, and Southeast Asia are not provided in the available sources.

Specific information regarding Organosyn Life Sciences Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history is not readily available in the provided sources. The company's manufacturing facility, Evertogen Lifesciences Ltd., has received approvals from regulatory agencies such as the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. However, details pertaining to the FDA are not specified.

Organosyn Life Sciences Private Limited's manufacturing facility, Evertogen Lifesciences Ltd., has received approvals from various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine. However, specific information regarding WHO prequalification, EU GMP certificates, and EDQM status is not available in the provided sources.

Specific details regarding Organosyn Life Sciences Private Limited's CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not readily available in the provided sources. The company's manufacturing facility, Evertogen Lifesciences Ltd., has received approvals from various international regulatory agencies, indicating compliance with global quality standards. However, information pertaining to Indian regulatory approvals is not specified.

There is no publicly available information regarding recent regulatory actions such as Form 483 observations, warning letters, or import alerts concerning Organosyn Life Sciences Private Limited. The company's manufacturing facility, Evertogen Lifesciences Ltd., has received approvals from various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. However, specific details regarding recent regulatory actions are not provided in the available sources.

Organosyn Life Sciences Private Limited operates in the competitive pharmaceutical industry, focusing on the manufacture and marketing of high-quality generic formulations. The company's manufacturing facility, Evertogen Lifesciences Ltd., has received approvals from various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. However, specific information regarding the company's market share, top competitors, and head-to-head analysis is not readily available in the provided sources.

Organosyn Life Sciences Private Limited differentiates itself through its manufacturing facility, Evertogen Lifesciences Ltd., which has an annual capacity of approximately 2 billion units. The facility is approved by various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. Additionally, the company's acquisition of Synmedic Ltd.'s branded formulation business in 2011 has enabled it to establish a marketing base in Ukraine and Central Asia, expanding its global footprint.

Organosyn Life Sciences Private Limited's current strategic direction focuses on the manufacture and marketing of high-quality generic pharmaceutical formulations. The company's manufacturing facility, Evertogen Lifesciences Ltd., has an annual capacity of approximately 2 billion units and is approved by various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. The acquisition of Synmedic Ltd.'s branded formulation business in 2011 has enabled the company to establish a marketing base in Ukraine and Central Asia, expanding its global footprint. Specific information regarding the company's focus on generics, specialty drugs, biosimilars, or Contract Development and Manufacturing Organization (CDMO) services is not readily available in the provided sources.

Organosyn Life Sciences Private Limited has demonstrated a consistent track record in the pharmaceutical industry, focusing on the manufacture and marketing of high-quality generic formulations. The company's manufacturing facility, Evertogen Lifesciences Ltd., has an annual capacity of approximately 2 billion units and is approved by various regulatory agencies, including the UK's MHRA, Australia's TGA, Health Canada, and SAUMP Ukraine, indicating compliance with international quality standards. The acquisition of Synmedic Ltd.'s branded formulation business in 2011 has enabled the company to establish a marketing base in Ukraine and Central Asia, expanding its global footprint. Specific details regarding the company's export volume, consistency, and reliability indicators are not readily available in the provided sources.

Importers should verify the following certifications when considering Organosyn Life Sciences Private Limited as a supplier:

• FDA Facility Registration: To ensure compliance with U.S. regulatory standards.

• WHO-GMP Certification: To confirm adherence to World Health Organization Good Manufacturing Practices.

• EU GMP Certification: To verify compliance with European Union Good Manufacturing Practices.

• ISO Certification: To