Synapse Pharmatech

Synapse Pharmatech, established in 2009, is an India-based pharmaceutical company specializing in the manufacture and export of finished pharmaceutical formulations. The company is headquartered in Ahmedabad, Gujarat, India, with additional facilities in North India and South India. Synapse Pharmatech operates as a privately held entity, with its ownership structure not publicly disclosed. The company's Corporate Identification Number (CIN) is not available in the provided sources. While specific revenue figures are not publicly disclosed, Synapse Pharmatech has reported a total export value of $511,000 USD from 11 shipments between 2022 and 2026. The company offers a diverse portfolio of over 200 finished formulations across various therapeutic categories, including respiratory, oncology, and biologicals. Synapse Pharmatech's official website is www.synapsepharmatech.com.

Synapse Pharmatech operates multiple manufacturing facilities across India, each specializing in different product categories:

• Unit 1 – North India: This facility is approved by ANVISA Brazil, INVIMA Colombia, PICS, and the European Union. It specializes in oncology, antivirals, general injectables, cephalosporins, hormones, oral solid dosage forms (OSD), ointments, and creams.

• Unit 2 – Ahmedabad, Gujarat: Certified by WHO-GMP, this plant focuses on hormones, OSD general and cardiovascular/gastrointestinal products, and offers sachet filling capabilities.

• Unit 3 – Gujarat, India: Approved by the European Union, this facility specializes in general injectables, cephalosporins, betalactams, and sterile drops.

• Unit 4 – South India: With WHO-GMP approval, this plant is dedicated to biologicals and plasma products.

• Unit 5 – North India: Certified by PICS, this facility manufactures tablets, capsules, dry powder inhalers, nasal sprays, and oral liquids.

These facilities are equipped to produce a wide range of pharmaceutical products, ensuring compliance with international quality standards.

Synapse Pharmatech is led by a team of experienced professionals:

• Pharm. Shalaka Mishra – Managing Director: With over 26 years in the pharmaceutical industry, Shalaka holds a gold medal in Masters in Pharmaceutical Sciences (M.Pharm). Her expertise spans pharma-academics, API industry, and finished formulation industry. She has successfully managed drug development projects for European customers and regulatory filings for USDMFs, as well as generic product development projects and submissions to regulatory authorities like TGA, MHRA, WHO-GDF, and various Latin American agencies.

• Pharm. Manish Mishra – Executive Director: With over 28 years in the pharmaceutical industry, including 18 years in international business development, Manish has traveled to more than 45 countries at a senior level. His expertise includes new market developments, partner connections, business development, and agreement finalizations. He has been instrumental in successful partner and Ministry of Health liaisoning, resulting in significant tenders and tech-transfer projects to regulated markets like Canada and the EU.

These leaders drive Synapse Pharmatech's strategic direction and growth in the global pharmaceutical market.

Synapse Pharmatech has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities are approved by various international regulatory bodies, such as the European Union, PICS, ANVISA Brazil, and INVIMA Colombia, indicating compliance with stringent quality standards. However, specific details regarding regulatory filings, approvals, and market access status in these regions are not publicly disclosed in the available sources. The company's focus on obtaining approvals from recognized regulatory agencies underscores its commitment to meeting international standards and expanding its global footprint.

Synapse Pharmatech has expanded its reach to emerging markets in Africa, Latin America, and Southeast Asia. The company's products are exported to Latin America, CIS, Southeast Asia, and Africa, with over 200 product registrations across five continents. Additionally, Synapse Pharmatech has established distribution partnerships in various countries, including Kenya, Tanzania, Ethiopia, Ghana, Ivory Coast, the Philippines, Nepal, Cambodia, Sri Lanka, Algeria, Turkey, Morocco, Egypt, Sudan, South Sudan, Nigeria, the Democratic Republic of Congo, Uganda, Zimbabwe, Namibia, Botswana, Malaysia, Myanmar, Vietnam, Australia, New Zealand, Papua New Guinea, Fiji, Azerbaijan, Ukraine, Uzbekistan, Russia, Georgia, Peru, Colombia, Mexico, Central America, Uruguay, Chile, Paraguay, Cuba, the Dominican Republic, Guyana, and several MENA and European countries. These partnerships facilitate market entry and distribution, enhancing Synapse Pharmatech's presence in these regions.

Synapse Pharmatech's geographic strategy demonstrates a diversified approach, with exports totaling $511,000 USD across 11 shipments between 2022 and 2026. The company's portfolio is concentrated, with its top five products accounting for 100% of its export value. This concentration indicates a reliance on a limited number of products for revenue generation. While the company has expanded into various international markets, the lack of diversification in its product portfolio may pose risks related to market fluctuations and regulatory changes. Strategic initiatives to diversify both product offerings and market presence could mitigate these risks and support sustainable growth.

Specific details regarding Synapse Pharmatech's FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly disclosed in the available sources. The company's focus on obtaining approvals from recognized regulatory agencies, such as the European Union, PICS, ANVISA Brazil, and INVIMA Colombia, indicates a commitment to meeting international quality standards. However, without publicly available information on FDA-related activities, a comprehensive assessment of the company's status with the FDA cannot be provided.

Synapse Pharmatech's manufacturing facilities are certified by WHO-GMP and EU GMP, reflecting compliance with international quality standards. These certifications are crucial for market access in various regions, including the European Union and other countries that recognize WHO-GMP and EU GMP standards. The company's adherence to these standards underscores its commitment to producing high-quality pharmaceutical products.

Specific details regarding Synapse Pharmatech's CDSCO manufacturing licenses, state drug controller approvals, and export NOCs are not publicly disclosed in the available sources. The company's adherence to international quality standards, as evidenced by WHO-GMP and EU GMP certifications, suggests compliance with Indian regulatory requirements. However, without publicly available information on CDSCO and state drug controller approvals, a comprehensive assessment of the company's regulatory standing within India cannot be provided.

As of March 2026, there are no publicly available records of FDA Form 483 observations, warning letters, or import alerts associated with Synapse Pharmatech. The company's adherence to international quality standards, as evidenced by WHO-GMP and EU GMP certifications, suggests a commitment to maintaining compliance with regulatory requirements. However, without publicly available information on recent regulatory actions, a comprehensive assessment cannot be provided.

Synapse Pharmatech operates in a competitive landscape with several key players in the pharmaceutical industry. While specific competitors in overlapping categories are not publicly disclosed, the company's focus on niche biopharmaceuticals, including albumin and IVIG injections, as well as oncology products, positions it in specialized market segments. The company's adherence to international quality standards, as evidenced by WHO-GMP and EU GMP certifications, enhances its competitiveness in regulated markets. However, the lack of diversification in its product portfolio, with the top five products accounting for 100% of its export value, may limit its ability to compete across a broader range of therapeutic areas.

Synapse Pharmatech's key differentiators include its specialization in niche biopharmaceuticals, such as albumin and IVIG injections, and its focus on state-of-the-art oncology products and depot injections like leuprolide. The company's adherence to international quality standards, as evidenced by WHO-GMP and EU GMP certifications, underscores its commitment to producing high-quality pharmaceutical products. Additionally, Synapse Pharmatech's extensive network of distribution partnerships across various regions facilitates market access and enhances its global presence.

Synapse Pharmatech's current strategic direction focuses on the manufacture and export of finished pharmaceutical formulations, with a particular emphasis on niche biopharmaceuticals and specialized products. The company's adherence to international quality standards, as evidenced by WHO-GMP and EU GMP certifications, supports its position in regulated markets. However, the lack of diversification in its product portfolio, with the top five products accounting for 100% of its export value, may pose risks related to