Acme Generics LLP

Acme Generics LLP, established on March 13, 2015, in Chandigarh, India, specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company was registered under the Corporate Identification Number (CIN) AAD-5392. In April 2021, Ruby Shah and Viral Shah were appointed as Designated Partners, overseeing the company's strategic direction and operations. Acme Generics operates from its headquarters at Plot No-75, Industrial Area, Phase-1, Chandigarh, India.

In the fiscal year ending March 31, 2021, Acme Generics reported a 13.33% increase in total revenue, reflecting its growing presence in the pharmaceutical export market. The company's net worth remained stable, indicating consistent financial health. Acme Generics is recognized for its expertise in niche segments such as oral hormones, including female sex hormones and levothyroxine, as well as liquid and lyophilized injectables.

Acme Generics operates a state-of-the-art manufacturing facility in Northern India, encompassing over 500,000 square feet of space. This facility is equipped to produce 17 billion tablets, 3 billion capsules, 30 million liquid vials/ampoules, and 12 million lyophilized vials annually. The plant specializes in the production of oral solid dosage forms, including tablets and capsules, as well as liquid and lyophilized injectables. Additionally, Acme Generics has expanded its sterile manufacturing capacity to produce an additional 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 annually.

The leadership team at Acme Generics includes Designated Partners Ruby Shah and Viral Shah, who have been instrumental in steering the company's strategic initiatives and operational growth. Their leadership has been pivotal in expanding the company's manufacturing capabilities and enhancing its product portfolio. Under their guidance, Acme Generics has achieved significant milestones, including the expansion of its sterile manufacturing capacity and the attainment of various international regulatory approvals.

Acme Generics has established a strong 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 USFDA, UK-MHRA, EU-GMP (Hungary), Health Canada, TGA Australia, ANVISA (Brazil), INVIMA (Colombia), 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's adherence to Good Manufacturing Practices (GMP) and other regulatory standards has facilitated its entry and sustained operations in these regions.

Acme Generics has strategically expanded its footprint into emerging markets across Africa, Latin America, and Southeast Asia. The company's products are available in countries such as Nigeria, Ghana, Uganda, Kenya, Nepal, Sri Lanka, the Philippines, Vietnam, Cambodia, Laos, Thailand, Yemen, Myanmar, Brazil, Colombia, Guatemala, Nicaragua, Paraguay, Uruguay, Chile, Costa Rica, Venezuela, and Peru. The attainment of WHO prequalification and other international certifications has enabled Acme Generics to access these markets, ensuring that its products meet global quality standards and are accessible to a broader patient population.

Acme Generics has adopted a diversified geographic strategy, expanding its operations across multiple continents, including North America, Europe, Africa, Asia, and Latin America. This global presence mitigates concentration risk and positions the company to leverage growth opportunities in various regions. The strategic direction focuses on enhancing market penetration through regulatory approvals and establishing partnerships with local distributors and healthcare providers. By diversifying its geographic footprint, Acme Generics aims to achieve sustainable growth and resilience in the dynamic pharmaceutical export market.

Acme Generics has achieved significant milestones in the U.S. market, with 38 Abbreviated New Drug Applications (ANDAs) approved and 18 filed and under review. The company has a target of obtaining over 50 ANDA approvals by 2025, reflecting its commitment to expanding its product offerings in the U.S. market. These approvals demonstrate Acme Generics' adherence to the stringent standards set by the U.S. Food and Drug Administration (FDA) and its capability to deliver high-quality generic pharmaceutical products to the U.S. market.

Acme Generics has been audited and approved by various international regulatory agencies, including the USFDA, UK-MHRA, EU-GMP (Hungary), Health Canada, TGA Australia, ANVISA (Brazil), INVIMA (Colombia), and WHO-Geneva. These certifications attest to the company's compliance with Good Manufacturing Practices (GMP) and its commitment to maintaining high-quality manufacturing standards. The EU GMP certification, in particular, enables Acme Generics to market its products within the European Union, ensuring that they meet the rigorous quality standards required by European regulators.

Acme Generics holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company has also obtained approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating its export operations. These regulatory approvals ensure that Acme Generics' products comply with Indian pharmaceutical standards and are eligible for export to various international markets. The company's adherence to CDSCO regulations underscores its commitment to maintaining high-quality manufacturing practices and regulatory compliance.

As of March 2026, there are no publicly available records indicating that Acme Generics has received any Form 483 observations, warning letters, or import alerts from regulatory authorities. This absence suggests that the company maintains a strong compliance record and adheres to the regulatory standards set by agencies such as the FDA, EMA, and WHO. The lack of such regulatory actions reflects positively on Acme Generics' commitment to quality and regulatory compliance.

Acme Generics operates in a competitive landscape with several key players in the pharmaceutical export market. Competitors include established Indian pharmaceutical exporters such as Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Lupin Pharmaceuticals. While Acme Generics holds a 1.5% market share in the salicylic product category, it faces competition from these larger entities with more extensive product portfolios and market reach. However, Acme Generics' focus on niche segments like oral hormones and its commitment to quality manufacturing standards provide it with a competitive edge in specific therapeutic areas.

Acme Generics' unique strengths include its specialization in niche segments such as oral hormones, including female sex hormones and levothyroxine, as well as liquid and lyophilized injectables. The company's manufacturing facility in Northern India, spanning over 500,000 square feet, enables it to produce a high volume of pharmaceutical products annually. Additionally, Acme Generics' attainment of various international regulatory approvals, including those from the USFDA, UK-MHRA, EU-GMP, and WHO-Geneva, underscores its commitment to maintaining high-quality manufacturing standards and regulatory compliance.

Acme Generics is strategically positioned as a Contract Development and Manufacturing Organization (CDMO), focusing on the production of generic oral solid and sterile drug products. The company's future outlook includes expanding its product portfolio through additional ANDA approvals and enhancing its presence in both regulated and emerging markets. By leveraging its manufacturing capabilities and regulatory expertise, Acme Generics aims to strengthen its position in the global pharmaceutical export market and achieve sustainable growth.

Acme Generics has demonstrated a consistent track record in pharmaceutical manufacturing, with a total export value of $738,000 USD across 41 shipments from 2022 to 2026. The company's portfolio includes four products across three therapeutic categories, with a concentration of 100% in its top five products. This focus indicates a strategic approach to product development and market positioning. The company's adherence to international regulatory standards and its expansion into various global markets reflect its reliability and commitment to quality.