Acme Generics Private Limited

Acme Generics Private Limited is a privately held pharmaceutical company based in Mohali, Punjab, India. Established on July 30, 2021, the company specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The Corporate Identification Number (CIN) assigned to Acme Generics is U24100PB2021PTC056566. As of March 2026, the company reports an authorized capital of ₹121.44 crore and a paid-up capital of ₹120.10 crore. The registered office is located at Plot No. 132, 2nd Floor, Sector 82, JLPL, Mohali, Punjab, 140308.

Acme Generics has demonstrated significant growth since its inception, with a total export value of $7.1 million USD and 285 shipments across six products in five therapeutic categories. The company's product portfolio is notably concentrated, with the top five products accounting for 93.6% of total exports. This concentration underscores the company's strategic focus on specific high-demand pharmaceutical formulations.

Acme Generics operates state-of-the-art manufacturing facilities designed to produce a diverse range of pharmaceutical products. The company's manufacturing plant is strategically located in Baddi, Himachal Pradesh, a region known for its pharmaceutical manufacturing infrastructure. The facility boasts an annual production capacity of 60 million general liquid and lyophilized vials, 60 million liquid and lyophilized vials for oncology, 30 million three-piece ophthalmic containers, and 24 million pre-filled syringes and cartridges. This expansive capacity enables Acme Generics to meet both domestic and international demand effectively.

The leadership team at Acme Generics Private Limited comprises experienced professionals committed to steering the company towards its strategic objectives. Viral Shah serves as the Director, bringing a wealth of experience in pharmaceutical operations and strategic management. Vikas Sharma holds the position of Whole-Time Director, overseeing day-to-day operations and ensuring the alignment of manufacturing processes with regulatory standards. Ginny Uppal serves as the Company Secretary, responsible for ensuring compliance with corporate governance norms and facilitating effective communication between the board of directors and stakeholders.

Acme Generics has established a robust presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has been audited and approved by various international regulatory agencies, including the US FDA, UK MHRA, EU GMP, Health Canada, TGA Australia, ANVISA, INVIMA, and WHO Geneva. These approvals underscore Acme Generics' commitment to maintaining high-quality manufacturing standards and its capability to meet the stringent requirements of these markets. The company has received approvals across major emerging markets in Asia, Africa, CIS, and Latin America, further expanding its global footprint.

Acme Generics has strategically penetrated emerging markets in Africa, Latin America, and Southeast Asia. The company's adherence to WHO prequalification standards has facilitated access to these regions, enabling it to supply essential medicines to underserved populations. By aligning its manufacturing processes with WHO guidelines, Acme Generics ensures the safety, efficacy, and quality of its products, thereby enhancing its reputation and market share in these emerging markets.

Acme Generics' geographic strategy reflects a balanced approach to market diversification and risk management. While the company has a strong presence in regulated markets, it has also made significant inroads into emerging markets, thereby reducing dependence on any single region. This diversification strategy mitigates concentration risk and positions the company for sustainable growth across various global markets.

Acme Generics has achieved significant milestones in the U.S. market, with 38 Abbreviated New Drug Applications (ANDAs) approved and 18 ANDAs filed and under review. The company's manufacturing facility has been audited and approved by the U.S. Food and Drug Administration (FDA), affirming its compliance with stringent U.S. regulatory standards. This approval not only facilitates the marketing of Acme Generics' products in the U.S. but also enhances the company's credibility in other regulated markets.

Acme Generics has obtained Good Manufacturing Practice (GMP) certifications from the World Health Organization (WHO) and the European Union (EU). These certifications validate the company's commitment to maintaining high-quality manufacturing standards and its capability to produce pharmaceutical products that meet international quality benchmarks. The EU GMP certification, in particular, opens avenues for the company to market its products across EU member states, thereby expanding its reach in the European market.

In India, Acme Generics holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with national regulatory standards. The company has also obtained approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating the export of its products to various international markets. These regulatory clearances reflect Acme Generics' adherence to both domestic and international pharmaceutical regulations.

As of March 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued against Acme Generics Private Limited. This absence of adverse regulatory actions suggests that the company maintains a strong compliance record and adheres to the regulatory standards set by authorities such as the FDA, WHO, and CDSCO.

Acme Generics operates in a competitive landscape with several key players in the pharmaceutical manufacturing sector. While specific market share data is not publicly available, the company's focus on high-demand products such as Levothyroxine, Acetaminophen, Loperamide, Salicylic, and Mycophenolate positions it favorably in the market. The company's adherence to international quality standards and its strategic focus on both regulated and emerging markets enhance its competitive edge.

Acme Generics' key differentiators include its specialized expertise in oral hormones, particularly female sex hormones and Levothyroxine, as well as its capabilities in liquid and lyophilized injectables. The company's substantial manufacturing capacity, including the production of 60 million general liquid and lyophilized vials annually, underscores its ability to meet large-scale demand. Additionally, Acme Generics' global regulatory approvals and certifications from agencies such as the FDA, WHO, and EU GMP highlight its commitment to quality and compliance.

Acme Generics is strategically positioned as a leading Contract Development and Manufacturing Organization (CDMO), focusing on the development, registration, and commercialization of generic oral solid and sterile drug products across both regulated and emerging markets. The company's future outlook includes expanding its portfolio, increasing ANDA approvals, and enhancing its presence in global markets. With a target of 50+ ANDA approvals by 2025, Acme Generics is poised for sustained growth and innovation in the pharmaceutical industry.

Acme Generics has demonstrated a strong track record in pharmaceutical manufacturing, with a total export value of $7.1 million USD and 285 shipments across six products in five therapeutic categories. The company's manufacturing facility in Baddi, Himachal Pradesh, is equipped with substantial production capacity, enabling it to meet both domestic and international demand effectively. The absence of adverse regulatory actions and the company's adherence to international quality standards further attest to its reliability as a supplier.

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

• FDA Approval: Confirm the company's FDA registration status and approved ANDAs through the FDA's official database.

• WHO-GMP Certification: Verify the WHO-GMP certification by consulting the WHO's official list of prequalified manufacturers.

• EU GMP Certification: Check the EU GMP certification status through the European Medicines Agency (EMA) or the European Directorate for the Quality of Medicines & HealthCare (EDQM).

• ISO Certification: Request copies of ISO certification documents from the company and verify their authenticity through the International Organization for Standardization (ISO) database.

When conducting due diligence on Acme Generics Private Limited, consider the following steps:

• Regulatory Compliance: Review the company's certifications and approvals from relevant regulatory bodies such as the FDA, WHO, EU, and CDSCO.

• Financial Health